The Effect of Neu-P11 on Symptoms in Patients With D-IBS

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT01558284

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS, 20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea- Irritable Bowel Syndrome	Drug: Neu-P11 Drug: Placebo

Detailed Description

This study aims to test a possible beneficial effect of NEU-P11 in patients with IBS.

The effect on symptoms will be rated by symptom scores. The primary endpoint will be the symptomatic benefit reported by the patient answering the simple question: Did your symptoms improve compared to prior to the clinical trial.

Additional secondary endpoints will capture sleep quality, changes in stool texture and individual symptom scores employing standardized symptom scores.

The study design is a 4 week, randomised, placebo-controlled, double blind study where 40 patients receive either placebo (20) or NEU-P11 (20). In the mid of the four week time of the Study the dose can be doubled of the patient does not recognize any relief of the D-IBS.

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Outcome Measures

Primary Outcome Measures

The relief of symptoms of the D-IBS by the study medication. [after each week for the time of study]
Only one question at the end of each visit and of each telephone call

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects age 18-80 years old
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.

Subject has IBS confirmed by the Rome III diagnostic criteria

Exclusion Criteria:

Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis.
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
Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy.
Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy.
Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse.
Subject is pregnant or lactating
Subject has history of human immunodeficiency virus (HIV) or hepatitis (B or C)
Subject has any condition or circumstance that could cause noncompliance with treatments or visits
Subject has active malignancy within the last 5 years.
Subject taking antipsychotic drugs, antispasmodics, antidiarrheals (e.g. loperamide, lubiprostone and bismuth subsalicylate), narcotics, prokinetic drugs, drugs indicated for IBS (e.g Alosetron), or warfarin.