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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01809587
First received: March 7, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Constipation
Irregular Bowel Movement Frequency
Device: IQP-PO-101
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Bowel movement frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Bristol Stool Form Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Subjects will keep a record of their stool form, for each bowel movement.

  • Straining at the start/ end of defecation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.

  • Feeling of incomplete evacuation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.

  • Evaluation of efficacy by subjects [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").

  • Evaluation of efficacy by investigator [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  • Full blood count [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)

  • Clinical chemistry [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  • Safety evaluation by investigators [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  • Adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809587

Locations
Germany
Analyze & Realize Ag
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01809587     History of Changes
Other Study ID Numbers: INQ/026612
Study First Received: March 7, 2013
Last Updated: January 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014