NCT01558284

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diarrhea- Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Neu-P11	Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist
DRUG	Placebo	Placebo

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2012-03-20
• Last updated: 2014-02-05

Locations

1 site across 1 country: Germany