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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 July 2012 |
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Main ID: |
EUCTR2008-000214-71-IT |
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Date of registration:
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01/10/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Scientific title:
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DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF A 4-WEEK TREATMENT WITH ORAL DOSES OF MEN15596 IN IRRITABLE BOWEL SYNDROME - ND |
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Date of first enrolment:
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03/07/2008 |
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Target sample size:
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560 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000214-71 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: - same IMP used at different dosage
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Phase:
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Countries of recruitment
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Denmark
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Germany
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Italy
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Latvia
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Slovakia
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1- Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
2- Male or female patients aged 18 - 70 years.
3- Clinical diagnosis of IBS (all subtypes of IBS-d, IBS-c, IBS-m, or IBS-u) according to the following symptom-based criteria as per Rome III criteria:
Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
4. For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before the start of run-in period (Day -14).
5. Use of appropriate contraceptive methods throughout the entire study period and up to 30 days post-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous six months.
6. Normal physical examination or without clinically relevant abnormalities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. IBS patients having more than 3 bowel movements/day (for more than 1 day/ week) OR less than 2 bowel movements/week during the 2 week run in period.
2. Patients with organic abnormalities of the gastro-intestinal tract, including history of colonic or major abdominal surgery, (appendicectomy or hysterectomy excluded), current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
3. History of gluten enteropathy.
4. Lactose intolerance as assessed by response to diet.
5. Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
6. Previous diagnosis of Diabetes Mellitus (either type 1 or 2).
7. Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable from at least two months.
8. Major psychiatric, neurological or cardiovascular disorders.
9. Use of prohibited concurrent medication within 7 days prior to screening, namely:
antimuscarinic drugs;
analgesic drugs (opioid or non-steroidal anti-inflammatory drugs): NOTE: short term use of paracetamol is allowed for max 2 consecutive days);
antidepressants. NOTE: the use of a single antidepressant is only allowed when the drug type and its dose regimen has not been changed in the previous six months;
benzodiazepines. NOTE: the use of a single benzodiazepine is only allowed when it is administered as sleep-inducer and the drug type and its dose regimen has not been changed in the previous six months;
other medications for IBS. NOTE: short-term use of the antidiarrhoeal Loperamid and laxative Bisacodyl 7 days prior to screening is allowed in accordance with the use described under section 7.3.1.
10. Pregnancy or breastfeeding.
11. Hypersensitivity to the drug excipients.
12. Patients not able to understand or collaborate throughout the study.
13. Participation in other clinical trials in the previous 4 weeks.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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irritable bowel syndrome
MedDRA version: 9.1
Level: SOC
Classification code 10017947
Term: Gastrointestinal disorders
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Intervention(s)
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Product Name: ibodutant
Product Code: men15596
Pharmaceutical Form: Tablet
CAS Number: 522664-63-7
Current Sponsor code: men15596
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Response for relief of overall IBS symptoms (SGA), at the end of 4 weeks of treatment, where response is defined as at least two weeks with satisfactory relief during four weeks of treatment (50% rule).
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Secondary Objective: To assess the safety and tolerability of a 4-week oral MEN15596 treatment up to 60 mg once daily in IBS patients.
To evaluate the efficacy and safety and tolerability of MEN15596 in each subpopulation of IBS patients, namely diarrhoea-prevalent, constipation-prevalent, mix of both, and unsubtyped IBS (IBS-d, IBS-c, IBS-m, and IBS-u, respectively).
To make an overall assessment of efficacy and tolerability in order to select the dose to be tested in the subsequent Phase III clinical development.
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Main Objective: To evaluate the efficacy of three doses of MEN 15596 on IBS symptoms relief as compared to placebo in a broad population of irritable bowel syndrome (IBS) patients following a 4 week oral treatment.
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Secondary ID(s)
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nak-03
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2008-000214-71-GB
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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