Back to resultsIQP-PO-101 for the Regulation of Bowel Movement Frequency
Primary Purpose
Constipation, Irregular Bowel Movement Frequency
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
IQP-PO-101
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
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
Sites / Locations
- Analyze & Realize Ag
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IQP-PO-101
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Bristol Stool Form Scale
Subjects will keep a record of their stool form, for each bowel movement.
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.
Pain during defecation
On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Feeling of incomplete evacuation
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
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
The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Full blood count
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
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.
Safety evaluation by subjects
The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Safety evaluation by investigators
The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01809587
Brief Title
IQP-PO-101 for the Regulation of Bowel Movement Frequency
Official Title
Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Irregular Bowel Movement Frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IQP-PO-101
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
IQP-PO-101
Primary Outcome Measure Information:
Title
Bowel movement frequency
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Bristol Stool Form Scale
Description
Subjects will keep a record of their stool form, for each bowel movement.
Time Frame
6 weeks
Title
Straining at the start/ end of defecation
Description
On a 100mm visual analogue scale (VAS), subjects will rate their feeling of straining at the start/ end of defecation for each bowel movement.
Time Frame
6 weeks
Title
Pain during defecation
Description
On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Time Frame
6 weeks
Title
Feeling of incomplete evacuation
Description
With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.
Time Frame
6 weeks
Title
Evaluation of efficacy by subjects
Description
The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").
Time Frame
4 weeks
Title
Evaluation of efficacy by investigator
Description
The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time Frame
4 weeks
Title
Full blood count
Description
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
Time Frame
4 weeks
Title
Clinical chemistry
Description
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.
Time Frame
4 weeks
Title
Safety evaluation by subjects
Description
The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time Frame
4 weeks
Title
Safety evaluation by investigators
Description
The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time Frame
4 weeks
Title
Adverse events
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Analyze & Realize Ag
City
Berlin
ZIP/Postal Code
10369
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
IQP-PO-101 for the Regulation of Bowel Movement Frequency
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