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

January 13, 2014 updated by: InQpharm Group

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 weeks
6 weeks
Bristol Stool Form Scale
Time Frame: 6 weeks
Subjects will keep a record of their stool form, for each bowel movement.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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").
4 weeks
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")
4 weeks
Full blood count
Time Frame: 4 weeks
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
4 weeks
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.
4 weeks
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")
4 weeks
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")
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InQpharm Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INQ/026612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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