Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Laboratoires Mayoly Spindler

ClinicalTrials.gov Identifier:

NCT01404923

First received: July 27, 2011

Last updated: November 18, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 27, 2011
Last Updated Date	November 18, 2011
Start Date ^ICMJE	December 2009
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 16, 2011)	Change from baseline in Irritable Bowel Syndrome Quality Of Life overall score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: July 27, 2011)	IBS-QOL scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01404923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Official Title ^ICMJE	Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
Brief Summary	The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies: Strategy A = MeteoSpasmyl®, on-demand therapy Strategy B = standard of care chosen by the physician
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Irritable Bowel Syndrome
Intervention ^ICMJE	Drug: anti spasmodic agents best standard of care prescriptions Drug: alverine citrate, simeticone on-demand therapy
Study Arm (s)	Experimental: meteospasmyl Intervention: Drug: alverine citrate, simeticone Active Comparator: standard of care Intervention: Drug: anti spasmodic agents
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	436
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: male or female ambulatory patients, aged > 18 years with IBS as defined by Rome III criteria for more than 1 year and less than 10 years with a C.Y FRANCIS score between 175 and 400 Exclusion Criteria: Acute diarrhea, bowel disorders due to an underlying cause Patient treated with MeteoSpasmyl® within the past 6 months Recent history of gastro intestinal surgery
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01404923
Other Study ID Numbers ^ICMJE	FMTO901
Has Data Monitoring Committee	No
Responsible Party	Laboratoires Mayoly Spindler
Study Sponsor ^ICMJE	Laboratoires Mayoly Spindler
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Laboratoires Mayoly Spindler
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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