IQP-CL-101 in IBS Management
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)
1 other identifier
interventional
100
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 21, 2013
CompletedFirst Posted
Study publicly available on registry
January 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 26, 2015
March 1, 2015
1.1 years
January 21, 2013
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IBS-SSS (Severity Symptom Score)
The questionnaire is to be completed by the subject
8 weeks
Secondary Outcomes (12)
IBS-GIS (Global Improvement Score)
8 weeks
IBS-QOL (Quality of Life)
8 weeks
Pain and discomfort diary
8 weeks
Efficacy assessment by investigator
8 weeks
Efficacy assessment by subject
8 weeks
- +7 more secondary outcomes
Study Arms (2)
IQP-CL-101
ACTIVE COMPARATOR2 softgels twice a day
Placebo
PLACEBO COMPARATOR2 softgels twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Barbara Grube
Berlin, State of Berlin, 10709, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Grube, MD
Private Practice
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2013
First Posted
January 24, 2013
Study Start
January 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 26, 2015
Record last verified: 2015-03