Back to resultsIQP-CL-101 in IBS Management
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
IQP-CL-101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, IBS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Barbara Grube
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IQP-CL-101
Placebo
Arm Description
2 softgels twice a day
2 softgels twice a day
Outcomes
Primary Outcome Measures
IBS-SSS (Severity Symptom Score)
The questionnaire is to be completed by the subject
Secondary Outcome Measures
IBS-GIS (Global Improvement Score)
The questionnaire is to be completed by the subject
IBS-QOL (Quality of Life)
The questionnaire is to be completed by the subject
Pain and discomfort diary
The diary is to be completed by the subject on a daily basis
Efficacy assessment by investigator
The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Efficacy assessment by subject
The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
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
Clinical chemistry
Venous blood samples are obtained at screening and the end of the study (8 weeks)
Fecal calprotectin
The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin
Blood pressure
Sitting blood pressure and heart rate will be measured using standard devices
Safety assessment by subject
The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Safety assessment by investigator
The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01774825
Brief Title
IQP-CL-101 in IBS Management
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, IBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IQP-CL-101
Arm Type
Active Comparator
Arm Description
2 softgels twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 softgels twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
IQP-CL-101
Intervention Description
2 softgels twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 softgels twice a day
Primary Outcome Measure Information:
Title
IBS-SSS (Severity Symptom Score)
Description
The questionnaire is to be completed by the subject
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
IBS-GIS (Global Improvement Score)
Description
The questionnaire is to be completed by the subject
Time Frame
8 weeks
Title
IBS-QOL (Quality of Life)
Description
The questionnaire is to be completed by the subject
Time Frame
8 weeks
Title
Pain and discomfort diary
Description
The diary is to be completed by the subject on a daily basis
Time Frame
8 weeks
Title
Efficacy assessment by investigator
Description
The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Time Frame
8 weeks
Title
Efficacy assessment by subject
Description
The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Time Frame
8 weeks
Title
Full blood count
Description
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
Time Frame
8 weeks
Title
Clinical chemistry
Description
Venous blood samples are obtained at screening and the end of the study (8 weeks)
Time Frame
8 weeks
Title
Fecal calprotectin
Description
The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin
Time Frame
8 weeks
Title
Blood pressure
Description
Sitting blood pressure and heart rate will be measured using standard devices
Time Frame
8 weeks
Title
Safety assessment by subject
Description
The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Time Frame
8 weeks
Title
Safety assessment by investigator
Description
The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Time Frame
8 weeks
Title
Adverse events
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Grube, MD
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Grube
City
Berlin
ZIP/Postal Code
10709
Country
Germany
12. IPD Sharing Statement
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IQP-CL-101 in IBS Management
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