Irritable Bowel Syndrome (IBS) MedDRA version: 14.0 Level: LLT Classification code 10021192 Term: IBS System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Neu P 11
Product Code: CAS
Pharmaceutical Form: Tablet
INN or Proposed INN: None Available
CAS Number: 946846-83-9
Current Sponsor code: University of Munich
Other descriptive name: Neu-
Sponsors
Klinikum der Universität
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects age 18-80 years old 2. Male or female Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are: - oral contraception - Double barrier type devices (e.g., male or female condom, diaphragm, contraceptive sponge) only in combination with a spermicide. - Intra-uterine devices in combination with a spermicide. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile. 3. Subject has IBS confirmed by the Rome III diagnostic criteria: 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis. 2. Subject has a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, celiac disease), GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis or ileus 3. Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy. 4. Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy. 5. Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse. 6. Subject is pregnant or lactating 7. Subject has history of human immunodeficiency virus (HIV) or hepatitis (B or C) 8. Subject has any condition or circumstance that could cause noncompliance with treatments or visits 9. Subject has active malignancy within the last 5 years. 10. Subject taking antipsychotic drugs, antispasmodics, antidiarrhaeals (e.g. loperamide, lubiprostone and bismuth subsalicylate), narcotics, prokinetic drugs, drugs indicated for IBS (e.g Alosteron), or warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Efficacy Endpoint The proportions of subjects who felt adequate relief of IBS symptoms for at least 2 of the 4 weeks of treatment will be served as the primary efficacy endpoint of the study. Adequate relief of IBS symptoms is defined as a response of "YES" to the following weekly (every 7 days) subject global relief question: "In regards to your IBS symptoms, compared to the way you felt before you started to take the study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [YES/NO]. Achieving adequate relief is another way of saying that in comparison with your typical experience of the disease before you have started taking the study medication, you feel that the symptoms of IBS have satisfactorily improved during the past 7 days. ;Secondary Objective: Secondary efficacy Endpoints (a)Change from baseline in IBS symptoms severity as assessed by the IBSSS after 4 weeks of double blind treatment. (b)Change in feeling of relief of individual IBS symptoms after 1,2,3 and 4 weeks of double blind treatment as compared baseline using the IBS symptom visual analogue scale (VAS). (c)Change from baseline in subjects' subjective assessment of quality of life using the IBS-QOL questionnaire after 4 weeks of double blind treatment. (d)Change from baseline in subjects' subjective assessment of quality of sleep using the Pittsburg Sleep Questionnaire Index (PSQI) parameters. (e)The proportions of subjects who felt adequate relief of IBS symptoms in the last 2 weeks of treatment with 20 mg dose as compared to 40 mg dose. ;Primary end point(s): The proportions of subjects who felt adequate relief of IBS symptoms for at least 2 of the 4 weeks of treatment will be served as the primary efficacy endpoint of the study. Adequate relief of IBS symptoms is defined as a response of "YES" to the following weekly (every 7 days) subject global relief question: "In regards to your IBS symptoms, compared to the way you felt before yo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (a) Change from baseline in IBS symptoms severity as assessed by the IBSSS after 4 weeks of double blind treatment. (b) Change in feeling of relief of individual IBS symptoms after 1,2,3 and 4 weeks of double blind treatment as compared baseline using the IBS symptom visual analogue scale (VAS). (c) Change from baseline in subjects' subjective assessment of quality of life using the IBS-QOL questionnaire after 4 weeks of double blind treatment. (d) Change from baseline in subjects' subjective assessment of quality of sleep using the Pittsburg Sleep Questionnaire Index (PSQI) parameters. (e) The proportions of subjects who felt adequate relief of IBS symptoms in the last 2 weeks of treatment with 20 mg dose as compared to 40 mg dose. ;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Germany
Contacts
Public ContactMartin Storr
LMU Munich
Outcome results
None listed