Clinical Trial Results:
A PHASE II/III, MULTI-CENTRE, PROSPECTIVE, EXPLORATORY, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH REFRACTORY DIARRHEA
(MEDICAL APPROACH OF REFRACTORY DIARRHEA)
Summary
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EudraCT number |
2009-009356-20 |
Trial protocol |
BE |
Global end of trial date |
09 Aug 2013
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Results information
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Results version number |
v2(current) |
This version publication date |
27 Feb 2016
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First version publication date |
01 Aug 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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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 |
I-48-52030-223
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
IPSEN NV
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Sponsor organisation address |
Guldensporenpark 87, Merelbeke, Belgium, 9820
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Public contact |
Medical Director, Gastroenterology, Ipsen, clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Gastroenterology, Ipsen, clinical.trials@ipsen.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 |
31 Oct 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Aug 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Aug 2013
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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 primary objective of the trial is to assess the effect of lanreotide autogel 120 mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.
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Protection of trial subjects |
The Sponsor was responsible for monitoring this data to verify that the rights and well-being of subjects were protected, that trial data were accurate (complete and verifiable to source data) and that the trial was conducted in compliance with the protocol, GCP and regulatory requirements.
All measurements and methods used in the study were standard.
The QOL questionnaires (SF-36 and IBS) are standardized and validated
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
02 Jul 2009
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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 |
Belgium: 36
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Worldwide total number of subjects |
36
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EEA total number of subjects |
36
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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) |
24
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was performed as a multicentre study at 18 investigational sites in Belgium of which 11 recruited patients. | ||||||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
42 [1] | ||||||||||||||||
Number of subjects completed |
36 | ||||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Inclusion/exclusion: 5 | ||||||||||||||||
Reason: Number of subjects |
Consent withdrawal: 1 | ||||||||||||||||
Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Worldwide numbers reported are per Treatment, ITT group. However, pre-assignment period is reported per Screened group. |
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Arm title
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Lanreotide Autogel 120 mg | ||||||||||||||||
Arm description |
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Lanreotides
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
120 mg of lanreotide. Open the case containing the prefilled syringe and remove the transparent plastic cover. Remove the needle sheath. Hold the syringe perpendicularly and inject deeply as a subcutaneous injection into the upper outer quadrant of the buttock.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
The Safety population was defined as all subjects who received at least one injection of the study medication. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lanreotide Autogel 120 mg
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Reporting group description |
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28. |
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End point title |
Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/ 24hours) in the Mean Number of Stools (mean of last 7 days) [1] | ||||||||||||
End point description |
Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods].
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End point type |
Primary
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End point timeframe |
Day 28
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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: No statistical analysis derived for primary end point. |
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No statistical analyses for this end point |
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End point title |
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS-QOL)} Compared to Baseline | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition.
IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL.
ITT Population, Analysis based on number (n) of patients with a valid value.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
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No statistical analyses for this end point |
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End point title |
Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline | ||||||||||||
End point description |
Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid.
ITT Population; Missing number of subjects = 1
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End point type |
Secondary
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End point timeframe |
Baseline (day 1), day 28 and day 56
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No statistical analyses for this end point |
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End point title |
Percent Change in Mean Number of Stools Compared to Baseline | ||||||||||||
End point description |
ITT Population; Missing number of subjects = 1
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Day 28 and Day 56
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects | ||||||||||||
End point description |
Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.
ITT Population; Missing number of subjects = 1.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), Day 28 and Day 56.
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No statistical analyses for this end point |
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End point title |
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools | ||||||||||||
End point description |
ITT Population; Missing number of subjects: 1.
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End point type |
Secondary
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End point timeframe |
Day 56
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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 |
Up to Day 56 (± 2)
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Adverse event reporting additional description |
Treatment Emergent Adverse Event (TEAE)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Adverse Events
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 Jun 2009 |
. Trial is phase II/III instead of phase III
. Oral contraception is not sufficient in view of the studied disease and should therefore be deleted form the eligibility criteria
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25 Jan 2012 |
The main reason for the amendment was to clarify the inclusion criterium 01 and to prolong the inclusion period. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |