Irritable Bowel SyndromePhase 3NCT01774825
IQP-CL-101 in IBS Management
A Phase 3 study testing IQP-CL-101 in people with Irritable Bowel Syndrome, run by InQpharm Group at 1 site in Germany.
Trial summary
After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- IQP-CL-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Feb 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfils Rome-III criteria for IBS diagnosis
- Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Who cannot join
- Known sensitivity to any of the ingredients of IQP-CL-101
- Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
- Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
- Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
- Clinically relevant excursions of safety parameters
- Any other conditions deemed relevant by the investigator(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-CL-101 in the Symptomatic Improvement of Irritable Bowel Syndrome (IBS)
After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms
- Conditions
- Irritable Bowel Syndrome
- Being tested
- IQP-CL-101, Placebo
- Keywords
- Irritable bowel syndrome, IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-CL-101Dietary supplement
2 softgels twice a day
PlaceboOther
2 softgels twice a day
| Study group | Role | What they receive |
|---|---|---|
| IQP-CL-101 | Active comparator | 2 softgels twice a day Receives: Dietary Supplement: IQP-CL-101 |
| Placebo | Placebo comparator | 2 softgels twice a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS (Severity Symptom Score)
The questionnaire is to be completed by the subject
Measured: 8 weeks
Secondary outcomes (12)
IBS-GIS (Global Improvement Score)
The questionnaire is to be completed by the subject
Measured: 8 weeks
IBS-QOL (Quality of Life)
The questionnaire is to be completed by the subject
Measured: 8 weeks
Pain and discomfort diary
The diary is to be completed by the subject on a daily basis
Measured: 8 weeks
Efficacy assessment by investigator
The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Measured: 8 weeks
Efficacy assessment by subject
The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Measured: 8 weeks
Full blood count
After sampling, venous blood samples will be transported on same day in cooler boxes to a central laboratory for analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes
Measured: 8 weeks
Clinical chemistry
Venous blood samples are obtained at screening and the end of the study (8 weeks)
Measured: 8 weeks
Fecal calprotectin
The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin
Measured: 8 weeks
Blood pressure
Sitting blood pressure and heart rate will be measured using standard devices
Measured: 8 weeks
Safety assessment by subject
The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Measured: 8 weeks
Safety assessment by investigator
The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Measured: 8 weeks
Adverse events
At all visits, subjects will be asked if any AE has occurred; such events will be recorded in the source documents and case report forms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Grube, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774825
- Sponsor's protocol ID
- INQ/028111
- Status last verified
- Mar 2015
- First submitted
- 21 Jan 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-CL-101 in the Symptomatic Improvement of Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT01774825
- Acronym / sponsor ID
- INQ/028111
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, IBS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Jan 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.
After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQP-CL-101 | Active comparator | Dietary Supplement: IQP-CL-1012 softgels twice a day |
| Placebo | Placebo comparator | Other: Placebo2 softgels twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfils Rome-III criteria for IBS diagnosis
- Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Key exclusion criteria (6 listed)
- Known sensitivity to any of the ingredients of IQP-CL-101
- Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
- Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
- Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
- Clinically relevant excursions of safety parameters
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-CL-1012 softgels twice a day | Dietary supplement | IQP-CL-101 |
| Placebo2 softgels twice a day | Other | Placebo |
Primary outcome
IBS-SSS (Severity Symptom Score)
Time frame: 8 weeks
The questionnaire is to be completed by the subject
12 secondary outcomes
IBS-GIS (Global Improvement Score)
Time frame: 8 weeks
IBS-QOL (Quality of Life)
Time frame: 8 weeks
Pain and discomfort diary
Time frame: 8 weeks
Efficacy assessment by investigator
Time frame: 8 weeks
Efficacy assessment by subject
Time frame: 8 weeks
Full blood count
Time frame: 8 weeks
Clinical chemistry
Time frame: 8 weeks
Fecal calprotectin
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Safety assessment by subject
Time frame: 8 weeks
Safety assessment by investigator
Time frame: 8 weeks
Adverse events
Time frame: 8 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 26 Mar 2015.
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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.
Barbara Grube, MD principal investigator
Private Practice
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-CL-101 in people with Irritable Bowel Syndrome, 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 3 inclusion and 6 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 26 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
IBS-SSS (Severity Symptom Score) (time frame: 8 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 26 Mar 2015.