THE EFFECT OF NEU-P11 ON SYMPTOMS IN PATIENTS WITH D-IBS

Phase 1

• Conditions: Irritable Bowel Syndrome (IBS); MedDRA version: 14.0Level: LLTClassification code 10021192Term: IBSSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002657-60-DE
• Lead Sponsor: Klinikum der Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-15
• Study Completion: 2013-06-23
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified