Status:
COMPLETED
IQP-PO-101 for the Regulation of Bowel Movement Frequency
Lead Sponsor:
InQpharm Group
Conditions:
Constipation
Irregular Bowel Movement Frequency
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
Eligibility Criteria
Inclusion
- A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported):
- Excessive straining
- Lumpy or hard stools
- Sensation of anorectal obstruc-tion
- A sense of incomplete evacua-tion of bowel movements
- A need for digital manipulation to facilitate evacuation
- Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period
- Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period
- Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period
- Written informed consent.
Exclusion
- Known sensitivity to the ingredients of the device
- Any organic gastrointestinal diseases, congenital or otherwise
- Presence of occult blood on screening
- Constipation that may have been drug-induced
- Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit
- Constipation other than idiopathic constipation
- Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01809587
Start Date
March 1 2013
End Date
August 1 2013
Last Update
January 14 2014
Active Locations (1)
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1
Analyze & Realize Ag
Berlin, State of Berlin, Germany, 10369