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

Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency

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

Study Overview

• Status: Completed
• Conditions: Constipation; Irregular Bowel Movement Frequency
• Intervention / Treatment: Device: IQP-PO-101

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize Ag

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IQP-PO-101; Day 1 to Day 7 - 1 sachet to be mixed in 250ml of water and consumed twice a day Day 8 to Day 28 - 1 sachet to be mixed in 250ml of water and consumed once a day Day 28 to Day 42 - no investigational product intake (post treatment observation only)	Device: IQP-PO-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel movement frequency	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.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InQpharm Group

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 10, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: INQ/026612