Clinical Trial Results:
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Summary
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EudraCT number |
2014-004132-20 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Jan 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Sep 2016
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First version publication date |
15 Sep 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D9423C00001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01514240 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
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Sponsor organisation address |
Grand Front Osaka Tower B, 3-11, Ofukacho, Kitaku, Osaka, Japan, 530-0011
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Public contact |
Masahiro Nii, Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan, 46 6-7711-4571, Masahiro.Nii@astrazeneca.com
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Scientific contact |
Masahiro Nii, Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan, 46 6-7711-4571, Masahiro.Nii@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.
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Protection of trial subjects |
If patients had any AE at the end of treatment, the AEs were followed by Investeigators until the investigators judged it was unnecessary to follow the AE.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Feb 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 112
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Worldwide total number of subjects |
112
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
109
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014. | ||||||||||||||||||
Pre-assignment
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Screening details |
Out of 123 enrolled subjects, 112 subjects were randomised and 11 subjects were not randomised. The reasons of no randomisation were 'Eligibility criteria not met' (9 subjects) and 'Adverse event' (2 subjects). | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Investigator, Monitor, Subject, Carer, Data analyst, Assessor | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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D9421-C 9mg + Mesalazine placebo | ||||||||||||||||||
Arm description |
Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
D9421-C
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
9 mg once daily
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Arm title
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Mesalazine 3g + D9421-C placebo | ||||||||||||||||||
Arm description |
Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Mesalazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1g three times a day
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Baseline characteristics reporting groups
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Reporting group title |
D9421-C 9mg + Mesalazine placebo
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Reporting group description |
Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mesalazine 3g + D9421-C placebo
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Reporting group description |
Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
D9421-C 9mg + Mesalazine placebo
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Reporting group description |
Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. | ||
Reporting group title |
Mesalazine 3g + D9421-C placebo
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Reporting group description |
Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. |
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End point title |
Proportion of patients with remission at Week 8 | |||||||||
End point description |
For the primary efficacy variable “Remission after 8 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.
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End point type |
Primary
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End point timeframe |
8 Week
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Statistical analysis title |
Remission rates at Week 8 | |||||||||
Statistical analysis description |
Remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.
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Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||
P-value |
= 0.526 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Difference of proportion | |||||||||
Point estimate |
5.4
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
-8.49 | |||||||||
upper limit |
18.94 | |||||||||
Notes [1] - A 2-sided 90% CI for the observed difference in the remission rates between the D9421-C 9mg group and the Mesalazine 3 g group was calculated using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than –10% in FAS Population. |
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End point title |
Proportion of patients with remission at Week 2 | |||||||||
End point description |
For the secondary efficacy variable “Remission after 2 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.
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End point type |
Secondary
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End point timeframe |
2 Week
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Statistical analysis title |
Remission rates at Week 2 | |||||||||
Statistical analysis description |
Remission rates at Week 2 for D9421-C 9 mg as compared to Mesalazine 3 g.
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Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.768 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Difference of proportion | |||||||||
Point estimate |
1.8
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
-8.54 | |||||||||
upper limit |
12.15 |
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End point title |
Proportion of patients with remission at Week 4 | |||||||||
End point description |
For the secondary efficacy variable “Remission after 4 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.
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End point type |
Secondary
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End point timeframe |
4 Week
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Statistical analysis title |
Remission rates at Week 4 | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.208 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Difference of proportion | |||||||||
Point estimate |
8.9
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
-2.87 | |||||||||
upper limit |
20.58 |
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End point title |
Change in CDAI scores from baseline to Week 2 | ||||||||||||
End point description |
Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The patients is asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit. The higher total CDAI score indicates severe condition and total CDAI score 150 less or equal is evaluated as a remission.
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End point type |
Secondary
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End point timeframe |
2 Week
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Statistical analysis title |
Change in CDAI scores from baseline to Weeks 2 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
106
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.058 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
LS mean difference between groups | ||||||||||||
Point estimate |
-22.8
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
-42.55 | ||||||||||||
upper limit |
-3.09 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
11.89
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End point title |
Change in CDAI scores from baseline to Week 4 | ||||||||||||
End point description |
Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The patients is asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit. The higher total CDAI score indicates severe condition and total CDAI score 150 less or equal is evaluated as a remission.
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End point type |
Secondary
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End point timeframe |
4 Week
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Statistical analysis title |
Change in CDAI scores from baseline to Weeks 4 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
105
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.014 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
-30
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
-49.95 | ||||||||||||
upper limit |
-9.96 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
12.05
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End point title |
Change in CDAI scores from baseline to Week 8 | ||||||||||||
End point description |
Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The patients is asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit. The higher total CDAI score indicates severe condition and total CDAI score 150 less or equal is evaluated as a remission.
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End point type |
Secondary
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End point timeframe |
8 Week
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Statistical analysis title |
Change in CDAI scores from baseline to Week 8 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
96
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.144 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
-21.4
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
-45.47 | ||||||||||||
upper limit |
2.74 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
14.53
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End point title |
Cumulative remission rate at Week 2 | ||||||||||||
End point description |
Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.
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End point type |
Secondary
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End point timeframe |
2 Week
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No statistical analyses for this end point |
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End point title |
Cumulative remission rate at Week 4 | ||||||||||||
End point description |
Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.
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End point type |
Secondary
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End point timeframe |
4 Week
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No statistical analyses for this end point |
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End point title |
Cumulative remission rate at Week 8 | ||||||||||||
End point description |
Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.
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End point type |
Secondary
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End point timeframe |
8 Week
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No statistical analyses for this end point |
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End point title |
Clinical improvement rates at Week 2 (70 points) | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
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End point type |
Secondary
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End point timeframe |
2 Week
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Statistical analysis title |
Clinical improvement rates at Weeks 2 (70 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
Method |
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Parameter type |
Difference of proportions | |||||||||
Point estimate |
14.3
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
0.5 | |||||||||
upper limit |
27.4 |
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End point title |
Clinical improvement rates at Week 4 (70 points) | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
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End point type |
Secondary
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End point timeframe |
4 Week
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Statistical analysis title |
Clinical improvement rates at Week 4 (70 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Difference of proportions | |||||||||
Point estimate |
16.1
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Confidence interval |
||||||||||
level |
90% | |||||||||
sides |
2-sided
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lower limit |
1.66 | |||||||||
upper limit |
29.61 |
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End point title |
Clinical improvement rates at Week 8 (70 points) | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.
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End point type |
Secondary
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End point timeframe |
8 Week
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Statistical analysis title |
Clinical improvement rate at Week 8 (70 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Difference of proportions | |||||||||
Point estimate |
16.1
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Confidence interval |
||||||||||
level |
90% | |||||||||
sides |
2-sided
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lower limit |
0.85 | |||||||||
upper limit |
30.29 |
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End point title |
Clinical improvement rates at Week 2 (100 points) | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
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End point type |
Secondary
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End point timeframe |
2 Week
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Statistical analysis title |
Clinical improvement rates at Week 2 (100 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
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Number of subjects included in analysis |
112
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Analysis specification |
Pre-specified
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|||||||||
Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Difference of proportions | |||||||||
Point estimate |
7.1
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Confidence interval |
||||||||||
level |
90% | |||||||||
sides |
2-sided
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lower limit |
-5.67 | |||||||||
upper limit |
19.71 |
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End point title |
Clinical improvement rates at Week 4 (100 points) | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
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End point type |
Secondary
|
|||||||||
End point timeframe |
4 Week
|
|||||||||
|
||||||||||
Statistical analysis title |
Clinical improvement rate at Week 4 (100 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
|||||||||
Number of subjects included in analysis |
112
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Difference of proportions | |||||||||
Point estimate |
14.3
|
|||||||||
Confidence interval |
||||||||||
level |
90% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.5 | |||||||||
upper limit |
27.4 |
|
||||||||||
End point title |
Clinical improvement rates at Week 8 | |||||||||
End point description |
Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
8 Week
|
|||||||||
|
||||||||||
Statistical analysis title |
Clinical improvement rate at Week 8 (100 points) | |||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
|||||||||
Number of subjects included in analysis |
112
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
||||||||||
Method |
||||||||||
Parameter type |
Difference of proportions | |||||||||
Point estimate |
12.5
|
|||||||||
Confidence interval |
||||||||||
level |
90% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-2.44 | |||||||||
upper limit |
26.68 |
|
|||||||||||||
End point title |
Change in total IBDQ scores from baseline to Week 2 | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in total IBDQ scores at Week 2 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
10.5
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
4.86 | ||||||||||||
upper limit |
16.14 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
3.4
|
|
|||||||||||||
End point title |
Change in total IBDQ scores from baseline to Week 4 | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in total IBDQ scores at Week 4 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
|||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
12.6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
6.07 | ||||||||||||
upper limit |
19.11 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
3.93
|
|
|||||||||||||
End point title |
Change in total IBDQ scores from baseline to Week 8 | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
8 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in total IBDQ scores at Week 8 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
12.6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
5.4 | ||||||||||||
upper limit |
19.72 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
4.31
|
|
|||||||||||||
End point title |
Change in total IBDQ scores from baseline to Week 10 | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
10 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in total IBDQ scores at Week 10 | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
95
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
14.1
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
6.9 | ||||||||||||
upper limit |
21.23 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
4.32
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 2 - Bowel function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W2 - Bowel function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
3.4
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.49 | ||||||||||||
upper limit |
5.29 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.14
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 4 - Bowel function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W4 - Bowel function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
3.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.64 | ||||||||||||
upper limit |
5.97 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.31
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 8 - Bowel function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
8 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W8 - Bowel function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
4.1
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.58 | ||||||||||||
upper limit |
6.64 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.53
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 10 - Bowel function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
10 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W10 - Bowel function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
95
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
3.3
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.9 | ||||||||||||
upper limit |
5.76 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.47
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 2 - Systemic symptom | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W2 - Systemic symptom | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.89 | ||||||||||||
upper limit |
3.17 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.69
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 4 - Systemic symptom | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W4 - Systemic symptom | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.73 | ||||||||||||
upper limit |
3.19 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.74
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 8 - Systemic symptom | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
8 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W8 - Systemic symptom | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
2.4
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.96 | ||||||||||||
upper limit |
3.76 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.84
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 10 - Systemic symptom | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
10 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W10 - Systemic symptom | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
95
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
2.6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.15 | ||||||||||||
upper limit |
4.09 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.89
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 2 - Emotional function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W2 - Emotional function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
3.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.44 | ||||||||||||
upper limit |
6.19 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.43
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 4 - Emotional function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W4 - Emotional function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
4.9
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
2.14 | ||||||||||||
upper limit |
7.65 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.66
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 8 - Emotional function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
8 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W8 - Emotional function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
4.3
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
1.4 | ||||||||||||
upper limit |
7.25 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.76
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 10 - Emotional function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
10 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W10 - Emotional function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
95
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
6.6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
3.56 | ||||||||||||
upper limit |
9.72 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
1.86
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 2 - Social function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
2 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W2 - Social function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
110
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
1.2
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.01 | ||||||||||||
upper limit |
2.43 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.73
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 4 - Social function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W4 - Social function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
1.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.42 | ||||||||||||
upper limit |
3.12 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.81
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 8 - Social function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
8 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W8 - Social function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
1.6
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.19 | ||||||||||||
upper limit |
3.04 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.86
|
|
|||||||||||||
End point title |
Change in IBDQ scores from baseline to Week 10 - Social function | ||||||||||||
End point description |
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
10 Week
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Change in IBDQ scores at W10 - Social function | ||||||||||||
Comparison groups |
D9421-C 9mg + Mesalazine placebo v Mesalazine 3g + D9421-C placebo
|
||||||||||||
Number of subjects included in analysis |
95
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
Method |
|||||||||||||
Parameter type |
LS mean difference between group | ||||||||||||
Point estimate |
1.3
|
||||||||||||
Confidence interval |
|||||||||||||
level |
90% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.15 | ||||||||||||
upper limit |
2.76 | ||||||||||||
Variability estimate |
Standard error of the mean
|
||||||||||||
Dispersion value |
0.85
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
D9421-C 9mg + Mesalazine placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mesalazine 3g + D9421-C placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
08 Dec 2011 |
Amendment 1 |
||
04 Apr 2012 |
Amendment 2 |
||
01 Mar 2013 |
Amendment 3 |
||
25 Sep 2013 |
Amendment 4 |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |