IQP-PO-101 for the Regulation of Bowel Movement Frequency

Phase 3

Completed

• Conditions: Constipation; Irregular Bowel Movement Frequency

• Registration Number: NCT01809587
• Lead Sponsor: InQpharm Group

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-10
• Study First Posted: 2013-03-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bowel movement frequency	6 weeks	Subjects will keep a record of the number of bowel movements, if any, from 00:00 hours to 23:59 hours (midnight to midnight) daily.

Secondary Outcome Measures

Name	Time	Method
Evaluation of efficacy by subjects	4 weeks	The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").
Bristol Stool Form Scale	6 weeks	Subjects will keep a record of their stool form, for each bowel movement.
Straining at the start/ end of defecation	6 weeks	On a 100mm visual analogue scale (VAS), subjects will rate their feeling of straining at the start/ end of defecation for each bowel movement.
Pain during defecation	6 weeks	On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Feeling of incomplete evacuation	6 weeks	With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.
Evaluation of efficacy by investigator	4 weeks	The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Full blood count	4 weeks	Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
Adverse events	6 weeks
Clinical chemistry	4 weeks	Venous blood samples are obtained at screening and the end of the treatment period (4 weeks) for measurements of uric acid, HbA1c and lipid profiles. An analysis will be done based on the change between the 2 periods.
Safety evaluation by subjects	4 weeks	The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Safety evaluation by investigators	4 weeks	The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

Trial Locations

Locations (1)

Analyze & Realize Ag; 🇩🇪 Berlin, Germany