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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404923
First Posted: July 28, 2011
Last Update Posted: January 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler
  Purpose

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

Condition Intervention Phase
Irritable Bowel Syndrome Drug: anti spasmodic agents Drug: alverine citrate, simeticone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

Further study details as provided by Laboratoires Mayoly Spindler:

Primary Outcome Measures:
  • Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score [ Time Frame: Baseline and 6 months ]
    Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.

  • Percentage of Improvement of the Total IBSQoL Scores [ Time Frame: Baseline and 6 Months ]
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage


Enrollment: 436
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: meteospasmyl Drug: alverine citrate, simeticone
on-demand therapy
Active Comparator: standard of care Drug: anti spasmodic agents
best standard of care prescriptions

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 IBS-SSS 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901
First Submitted: July 27, 2011
First Posted: July 28, 2011
Results First Submitted: October 14, 2014
Results First Posted: November 4, 2014
Last Update Posted: January 23, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Parasympatholytics
Alverine
Mebeverine
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants