The Effect of Neu-P11 on Symptoms in Patients With D-IBS
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.
|Study Design:||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)|
- The relief of symptoms of the D-IBS by the study medication. [ Time Frame: after each week for the time of study ] [ Designated as safety issue: Yes ]Only one question at the end of each visit and of each telephone call
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
|Klinikum Grosshadern Medizinische Klinik 2|
|Munich, Bavaria, Germany, 81377|
|Principal Investigator:||Martin Storr, Prof Dr.||Medizinische Klinik 2 LMU Muenchen|