A Phase 3 interventional study of IQP-PO-101 in Constipation and Irregular Bowel Movement Frequency, sponsored by InQpharm Group. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-14.
Sponsored by InQpharm Group · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
1,040 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →InQpharm Group is the lead sponsor of 29 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
Exclusion Criteria:
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
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.
Time frame: 6 weeks
Bristol Stool Form Scale
Subjects will keep a record of their stool form, for each bowel movement.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Pain during defecation
On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Time frame: 6 weeks
Feeling of incomplete evacuation
With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.
Time frame: 6 weeks
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").
Time frame: 4 weeks
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")
Time frame: 4 weeks
Full blood count
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
Time frame: 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.
Time frame: 4 weeks
Safety evaluation by subjects
The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time frame: 4 weeks
Safety evaluation by investigators
The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time frame: 4 weeks
Adverse events
Time frame: 6 weeks
The record gives a start of Mar 2013, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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