IQP-CL-101 in IBS Management | NCT01774825

Studies
IQP-CL-101 in IBS Management

NCT01774825

Sponsor

InQpharm Group

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Irritable Bowel Syndrome

Interventions

IQP-CL-101
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jan 21, 2013

First Submission Date that Met QC Criteria

Jan 21, 2013

First Posted Date

Jan 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IQP-CL-101	Active Comparator	2 softgels twice a day	Dietary Supplement: IQP-CL-101
Placebo	Placebo Comparator	2 softgels twice a day	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IQP-CL-101	Dietary Supplement	2 softgels twice a day	IQP-CL-101
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IBS-SSS (Severity Symptom Score)	The questionnaire is to be completed by the subject	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
IBS-GIS (Global Improvement Score)	The questionnaire is to be completed by the subject	8 weeks
IBS-QOL (Quality of Life)	The questionnaire is to be completed by the subject

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Barbara Grube, MD	Private Practice	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Barbara Grube		Berlin	State of Berlin	10709	Germany

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided