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.
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 Type
OBSERVATIONAL
Enrollment
40
Klinikum Grosshadern Medizinische Klinik 2
Munich, Bavaria, Germany
The relief of symptoms of the D-IBS by the study medication.
Only one question at the end of each visit and of each telephone call
Time frame: after each week for the time of study
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