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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
Results First Received: October 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome
Interventions: Drug: anti spasmodic agents
Drug: alverine citrate, simeticone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Meteospasmyl alverine citrate, simeticone: on-demand therapy
Standard of Care anti spasmodic agents: best standard of care prescriptions

Participant Flow:   Overall Study
    Meteospasmyl     Standard of Care  
STARTED     222     214  
COMPLETED     199     197  
NOT COMPLETED     23     17  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Meteospasmyl alverine citrate, simeticone: on-demand therapy
Standard of Care anti spasmodic agents: best standard of care prescriptions
Total Total of all reporting groups

Baseline Measures
    Meteospasmyl     Standard of Care     Total  
Number of Participants  
[units: participants]
  222     214     436  
Age  
[units: years]
Mean (Standard Deviation)
  53.8  (14.9)     55.1  (16.2)     54.4  (15.6)  
Gender  
[units: participants]
     
Female     160     160     320  
Male     62     54     116  
Region of Enrollment  
[units: participants]
     
France     222     214     436  



  Outcome Measures
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1.  Primary:   Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Percentage of Improvement of the Total IBSQoL Scores   [ Time Frame: Baseline and 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical trials Manager
Organization: Laboratoires Mayoly Spindler
phone: 33 134805555
e-mail: contact_essais_cliniques@mayoly-spindler.fr


Publications of Results:

Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901
Study First Received: July 27, 2011
Results First Received: October 14, 2014
Last Updated: November 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)