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Completed

NCT Number: NCT01809587

IQP-PO-101 for the Regulation of 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

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Key information

Conditions

Constipation Irregular Bowel Movement Frequency Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Analyze & Realize Ag

Berlin, State of Berlin, 10369, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IQP-PO-101

Device

Primary outcomes

  1. Bowel movement frequency

    Time frame: 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 outcomes

  1. Bristol Stool Form Scale

    Time frame: 6 weeks

    Subjects will keep a record of their stool form, for each bowel movement.

  2. Straining at the start/ end of defecation

    Time frame: 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.

  3. Pain during defecation

    Time frame: 6 weeks

    On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.

  4. Feeling of incomplete evacuation

    Time frame: 6 weeks

    With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.

  5. Evaluation of efficacy by subjects

    Time frame: 4 weeks

    The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").

  6. Evaluation of efficacy by investigator

    Time frame: 4 weeks

    The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  7. Full blood count

    Time frame: 4 weeks

    Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)

  8. Clinical chemistry

    Time frame: 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.

  9. Safety evaluation by subjects

    Time frame: 4 weeks

    The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  10. Safety evaluation by investigators

    Time frame: 4 weeks

    The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")

  11. Adverse events

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2013
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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