Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2013-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IQP-CL-101
2 softgels twice a day
IQP-CL-101
2 softgels twice a day
Placebo
2 softgels twice a day
Placebo
2 softgels twice a day
Interventions
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IQP-CL-101
2 softgels twice a day
Placebo
2 softgels twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
Yes
Sponsors
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InQpharm Group
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Grube, MD
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Locations
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Barbara Grube
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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INQ/028111
Identifier Type: -
Identifier Source: org_study_id
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