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

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ClinicalTrials.gov Identifier: NCT01404923
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: meteospasmyl Drug: alverine citrate, simeticone
on-demand therapy

Active Comparator: standard of care Drug: anti spasmodic agents
best standard of care prescriptions




Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Additional Information:
Publications of Results:
Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901
First Posted: July 28, 2011    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014
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