The Effect of Neu-P11 on Symptoms in Patients With D-IBS (Neu-P11)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01558284|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment|
|Diarrhea- Irritable Bowel Syndrome||Drug: Neu-P11 Drug: Placebo|
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|
|Actual Enrollment :||40 participants|
|Official Title:||Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
- 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 - antagonistOther Name: there are no other names
- Drug: Placebo
PlaceboOther Name: there are no other names
- The relief of symptoms of the D-IBS by the study medication. [ Time Frame: after each week for the time of study ]Only one question at the end of each visit and of each telephone call
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558284
|Klinikum Grosshadern Medizinische Klinik 2|
|Munich, Bavaria, Germany, 81377|
|Principal Investigator:||Martin Storr, Prof Dr.||Medizinische Klinik 2 LMU Muenchen|