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

NCT ID: NCT01809587

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-08-31

Brief Summary

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

Conditions

Constipation; Irregular Bowel Movement Frequency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

IQP-PO-101

Intervention Type: DEVICE

Interventions

IQP-PO-101

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Analyze & Realize Ag

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

INQ/026612

Identifier Type: -

Identifier Source: org_study_id