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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809587
• Other study ID #: INQ/026612
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2013
• Last updated: January 13, 2014
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irregular Bowel Movement Frequency

Intervention

Device:
• IQP-PO-101

Locations

Country	Name	City	State
Germany	Analyze & Realize Ag	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bristol Stool Form Scale	Subjects will keep a record of their stool form, for each bowel movement.	6 weeks	No
Secondary	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	No
Secondary	Pain during defecation	On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.	6 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Full blood count	Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)	4 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Adverse events		6 weeks	Yes