ConstipationPhase 3NCT01809587
IQP-PO-101 for the Regulation of Bowel Movement Frequency
A Phase 3 study testing IQP-PO-101 in people with Constipation and Irregular Bowel Movement Frequency, run by InQpharm Group at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Irregular Bowel Movement Frequency
- What is being tested?
- IQP-PO-101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Constipation, Irregular Bowel Movement Frequency
- Being tested
- IQP-PO-101
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-PO-101Device
| Study group | Role | What they receive |
|---|---|---|
| IQP-PO-101 | Experimental | 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) Receives: Device: IQP-PO-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (11)
Bristol Stool Form Scale
Subjects will keep a record of their stool form, for each bowel movement.
Measured: 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.
Measured: 6 weeks
Pain during defecation
On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Measured: 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.
Measured: 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").
Measured: 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")
Measured: 4 weeks
Full blood count
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
Measured: 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.
Measured: 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")
Measured: 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")
Measured: 4 weeks
Adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809587
- Sponsor's protocol ID
- INQ/026612
- Status last verified
- Jan 2014
- First submitted
- 7 Mar 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency
- ClinicalTrials.gov ID
- NCT01809587
- Acronym / sponsor ID
- INQ/026612
- Conditions
- Constipation, Irregular Bowel Movement Frequency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IQP-PO-101 | Experimental | Device: IQP-PO-101Day 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQP-PO-101 | Device | IQP-PO-101 |
Primary outcome
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.
11 secondary outcomes
Bristol Stool Form Scale
Time frame: 6 weeks
Straining at the start/ end of defecation
Time frame: 6 weeks
Pain during defecation
Time frame: 6 weeks
Feeling of incomplete evacuation
Time frame: 6 weeks
Evaluation of efficacy by subjects
Time frame: 4 weeks
Evaluation of efficacy by investigator
Time frame: 4 weeks
Full blood count
Time frame: 4 weeks
Clinical chemistry
Time frame: 4 weeks
Safety evaluation by subjects
Time frame: 4 weeks
Safety evaluation by investigators
Time frame: 4 weeks
Adverse events
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IQP-PO-101 in people with Constipation and Irregular Bowel Movement Frequency, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel movement frequency (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.