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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
Results First Submitted: October 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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
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