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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 3, 2014
Last verified: November 2014

July 27, 2011
November 3, 2014
December 2009
October 2011   (final data collection date for primary outcome measure)
  • Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
IBS-QOL scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01404923 on ClinicalTrials.gov Archive Site
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Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Drug: anti spasmodic agents
    best standard of care prescriptions
  • Drug: alverine citrate, simeticone
    on-demand therapy
  • Experimental: meteospasmyl
    Intervention: Drug: alverine citrate, simeticone
  • Active Comparator: standard of care
    Intervention: Drug: anti spasmodic agents
Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01404923
FMTO901
No
Laboratoires Mayoly Spindler
Laboratoires Mayoly Spindler
Not Provided
Not Provided
Laboratoires Mayoly Spindler
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP