Clinical Trial Results:
A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits
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Summary
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EudraCT number |
2013-000891-13 |
Trial protocol |
DE |
Global end of trial date |
17 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Dec 2016
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First version publication date |
10 Dec 2016
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Other versions |
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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 |
BAY98-7410/17155
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02246686 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Bayer AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,
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Public contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
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Scientific contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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 |
02 Dec 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Feb 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The objective of the present study was to assess the efficacy and safety of STW5-II as add-on treatment for induction of remission in subjects with mild to moderate ulcerative colitis (UC) in an acute flare, including remission rate, time to remission, quality of life.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
Subjects received mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks for induction of remission. Mesalazine was not provided by sponsor. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Nov 2014
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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 |
Germany: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
0
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Adults (18-64 years) |
3
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at multiple centers in Germany between 03 November 2014 (first subject first visit) and 17 February 2015 (last subject last visit). | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 3 subjects were screened. Of them all the 3 were randomized and treated. Two subjects completed the study and 1 subject dropped out. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (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 |
Subject, Investigator | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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STW5-II (BAY98-7410) | |||||||||||||||
Arm description |
Subject received STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks for induction of remission. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
STW5-II
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Investigational medicinal product code |
BAY98-7410
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Other name |
Iberogast N
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks.
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subjects received placebo of STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks and 58 days respectively for induction of remission. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received placebo of STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
STW5-II (BAY98-7410)
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Reporting group description |
Subject received STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks for induction of remission. | ||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo of STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks and 58 days respectively for induction of remission. | ||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
STW5-II (BAY98-7410)
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Reporting group description |
Subject received STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks for induction of remission. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo of STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks and 58 days respectively for induction of remission. | ||
Subject analysis set title |
Full Analysis Set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
FAS (N= 3) included all the randomized subjects who received study medication.
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Subject analysis set title |
Safety Analysis Set (SAF)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
SAF (N= 3) included all the randomised subjects who received at least one dose of study medication. It is not possible to calculate an "arithmetic mean" for the verum group (only 1 patient). This only applies to the placebo group (as long as data of at least data 2 patients are involved).
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End point title |
Percentage of Subjects With Remission at Final Visit (Week 12) Investigated With Clinical Activity Index (CAI) [1] | ||||||||||||
End point description |
Remission is defined as CAI less than or equal to (<=) 4. The CAI is a well-established and internationally used tool for assessment of remission and active ulcerative colitis (UC). The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points.
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End point type |
Primary
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End point timeframe |
Final visit (up to week 12)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [2] - FAS [3] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in Endoscopic Index [EI] [4] | ||||||||||||
End point description |
Endoscopic Index is used to evaluate UC severity. The Endoscopic index uses scores are based on granulation, vascular pattern, mucosal vulnerability, and mucosal damage. Based on granulation, the score ranges from 0 to 2. If granulation tissue is not present, a score of 0 is given, while its presence results in a score of 2. Vascular pattern: characterized as normal (0), faded (1), or absent (2). Vulnerability of mucosa: scored as having no bleeding (0), having contact bleeding (2), and having spontaneous bleeding (4). Mucosal damage: such as erosions and ulcers, mucus, and fibrin is characterized as none (0), slight(2) or pronounced (4). Total score was calculated as the sum of all the sub-scores, score range from 0-12, higher the score is higher the disease severity. Here, "99999" denotes that data was not calculated because standard deviation cannot be calculated as there was only one subject per arm.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [5] - FAS [6] - FAS and number of subjects evaluable for this end point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in Histological Index [HI] Based on Riley [7] | ||||||||||||
End point description |
HI was determined centrally based on Riley. Six histological features were assessed: acute inflammatory cell infiltration (polymorphonuclear cells in the lamina propria), chronic inflammatory cell infiltrate (round cells in the lamina propria), crypt abscesses, mucin depletion, surface epithelial integrity, crypt architectural irregularities. Each parameter was graded on a four point scale (0= none, 1= mild, 2= moderate, or 3= severe). Total score was calculated as the sum of all the sub-scores, score range: 0-18, higher score is higher disease severity. Here, "99999" denotes that data was not calculated because standard deviation cannot be calculated as there was only one subject per arm.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [8] - FAS [9] - FAS and number of subjects evaluable for this end point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects With Sustained Remission at Week 12 [10] | ||||||||||||
End point description |
Sustained Remission was defined as CAI <= 2. The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points.
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End point type |
Primary
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End point timeframe |
Final visit (up to week 12)
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [11] - FAS [12] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to Remission (Clinical Activity Index [CAI] Less Than or Equal to 4 Points) [13] | ||||||||||||
End point description |
Time to remission was the time in days from day 0 until first remission was reached. Remission was defined as CAI <= 4. The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points. ‘99999’ here indicates that data was not calculated. 95 percent (%) confidence intervals could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm and in the Placebo arm none of the subjects experienced remission.
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End point type |
Primary
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End point timeframe |
From baseline to Final visit (up to week 12)
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [14] - FAS [15] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to Sustained Remission (Clinical Activity Index [CAI] Less Than or Equal to 2 Points) [16] | ||||||||||||
End point description |
Time to sustained remission was the time in days from day 0 until first sustained remission was reached. Sustained Remission was defined as CAI <= 2. The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points. ‘99999’ here indicates that data was not calculated. 95 % confidence intervals could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm and in the Placebo arm none of the subjects experienced remission.
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End point type |
Primary
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End point timeframe |
From baseline to Final visit (up to week 12)
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [17] - FAS [18] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects Who Reached a Remission at Least Once During the Course of the Study [19] | |||||||||
End point description |
Remission is defined as CAI <= 4. The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points.
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End point type |
Primary
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End point timeframe |
From baseline to Final visit (up to week 12)
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [20] - FAS [21] - FAS |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects Who Reached a Sustained Remission at Least Once During the Course of the Study [22] | |||||||||
End point description |
Sustained Remission is defined as CAI <= 2. The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points.
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End point type |
Primary
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End point timeframe |
From baseline to Final visit (up to week 12)
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| Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [23] - FAS [24] - FAS |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change From Baseline to Final Visit of Absolute Clinical Activity Index (CAI) Values [25] | ||||||||||||
End point description |
The CAI is a well-established and internationally used tool for assessment of remission and active UC. The total index score ranges from 0 to 29 points. A mild or moderate UC can be defined as a CAI value ranging from 5 to 10 points. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [26] - FAS [27] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline to Final Visit in Inflammatory Bowel Disease Questionnaire (IBDQ-D) [28] | ||||||||||||
End point description |
IBDQ is an instrument that assesses quality of life in patients with inflammatory bowel disease. The four dimensions bowel, systemic, emotion and social are determined. Questionnaire comprises 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). Item scores range from 1 to 7 for each area evaluated. To calculate the total IBDQ score, add up scores for all 32 questions. Total IBDQ score ranges from 32 to 224. A higher score indicates better quality of life. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [29] - FAS [30] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline to Final Visit in Irritable Bowel Severity Score (IBSS) [31] | ||||||||||||
End point description |
Associated irritable bowel syndrome symptoms were investigated with IBSS. The IBSS contains 9 questions for estimation of symptoms of irritable bowel syndrome. The first five questions use a visual analogue scale. The scales were to evaluate severity of symptoms ranging from 0 to 100%. The total sum indicates the differentiation between mild, moderate and severe forms of IBS (less than [<] 75: control; 75-175: mild; 175-300: moderate; > 300: severe). The last four questions provide additional information regarding the symptoms of irritable bowel syndrome. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [32] - FAS [33] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline to Final Visit in EuroQol 5 Dimensions Questionnaire (EQ-5D) [34] | ||||||||||||||||||
End point description |
EQ-5D investigated the overall quality of life. The EQ-5D is approved for its validity and reliability in patients with UC. It comprises of a first part with five questions determining the dimensions: mobility, selfcare, usual activities, pain/discomfort, anxiety/depression in a three point sensitivity. For the first part (Question score) the score was calculated from index values based on TTO (Time Trade-Off) models for Germany according to Szende et al., 2007. The second score represents the patients’ markings on the visual analogue scale (VAS). Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [35] - FAS [36] - FAS |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change in Partial Mayo Score [37] | ||||||||||||
End point description |
The Mayo disease activity index consists of four components: bleeding, stool frequency (defined as fecal passage), physician assessment, and endoscopic appearance and are rated from 0-3. A partial Mayo score is the Mayo score minus the endoscopic subscore. The partial Mayo score could discriminate responders from non-responders relatively well. Score ranges from 0-9. Higher the score is, higher the disease severity. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [38] - FAS [39] - FAS |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in Mayo Score [40] | ||||||||||||
End point description |
The Mayo disease activity index consists of four components: bleeding, stool frequency (defined as fecal passage), physician assessment, and endoscopic appearance and are rated from 0-3. Score ranges from 0-12. Higher the score is, higher the disease severity. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 1 collected value was not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [41] - FAS [42] - FAS and number of subjects evaluable for this end point. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in Ulcerative Colitis Markers (Calprotectin, Lactoferrin, Polymorphonuclear [PMN]-Elastase) [43] | |||||||||||||||||||||
End point description |
Changes in the UC markers (calprotectin, lactoferrin, PMN-elastase) were determined for determination of parameters associated with acute flare of UC subjects. The combination of these parameters and C-reactive protein (reported below in the next end point) is able to differentiate between subjects with and without inflammation without using endoscopic measurements. The cutoffs for acute flare were: calprotectine > 48 microgram per gram (mcg/g); lactoferrin > 7.05 mcg/g; PMN elastase > 0.062 mcg/g. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
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End point type |
Primary
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End point timeframe |
Baseline and Final visit (up to week 12)
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| Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [44] - FAS [45] - FAS |
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| No statistical analyses for this end point | ||||||||||||||||||||||
|
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End point title |
Change in Ulcerative Colitis Marker (C-reactive Protein) [46] | ||||||||||||
End point description |
Changes in UC markers were determined for determination of parameters associated with acute flare of UC subjects. The combination of C-reactive protein and other parameters (calprotectin, lactoferrin, polymorphonuclear [PMN]-elastase reported in the above end point) is able to differentiate between subjects with and without inflammation without using endoscopic measurements. The cutoff for acute flare of C-reactive Protein was > 0.7 milligram per deciliter (mg/dL). Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
|
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End point type |
Primary
|
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End point timeframe |
Baseline and Final visit (up to week 12)
|
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| Notes [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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| Notes [47] - FAS [48] - FAS |
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| No statistical analyses for this end point | |||||||||||||
|
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End point title |
Change of Mesalazine Dose [49] | ||||||||||||
End point description |
Mesalazine was used as standard medication in acute flare of UC, dose and mode of administration according to guidelines in this study. Change of mesalazine dosage should had followed for medical reasons only. Here, ‘99999’ indicates that data was not calculated. Standard deviation could not be estimated for STW5-II arm because only 1 subject was evaluable for this arm. For Placebo arm, as there
were less than 3 subjects, standard deviation was not calculated because 2 or less collected values were not sufficient to give a reliable estimation.
|
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End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline and Final visit (up to week 12)
|
||||||||||||
| Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Inferential analysis were not performed due to early termination of the study because of less number of subjects involved. |
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|
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| Notes [50] - FAS [51] - FAS |
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| No statistical analyses for this end point | |||||||||||||
|
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|
Adverse events information
|
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Timeframe for reporting adverse events |
From baseline up to week 12
|
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
|
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|
Reporting groups
|
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Reporting group title |
STW5-II (BAY98-7410)
|
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Reporting group description |
Subject received STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks for induction of remission. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
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Reporting group description |
Subjects received placebo of STW5-II orally 20 drops liquid 3 times daily (3*20 drops liquid per day) for 12 weeks as add-on treatment to mesalazine oral dosing taken according to guideline recommendations for the treatment of an acute flare for 12 weeks and 58 days respectively for induction of remission. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| ‘99999’ in the posting indicates that data was not calculated due to very less number of subjects evaluable per arm. Due to premature termination of this study, data sets were not analysed. | |||
