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Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT00542295
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:
Laboratoires Mayoly Spindler

Brief Summary:
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: alverine citrate and simeticone Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: A Drug: alverine citrate and simeticone
Other Name: Meteospasmyl®

Placebo Comparator: B Drug: placebo



Primary Outcome Measures :
  1. Subject self assessment of abdominal pain/discomfort [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. IBS life impact, overall treatment assessment, concomitant factors [ Time Frame: Baseline and 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female ambulatory patients, aged 18-75 years
  • with IBS as defined by Rome III criteria

Exclusion Criteria:

  • Functional bowel disorder other than IBS,
  • Underlying cause for symptomatology, which excludes IBS diagnosis,
  • Gastro-intestinal cancer or significant gastro-intestinal surgical background,
  • Any acute/uncontrolled systemic pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542295


Locations
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1106
Budapest, Hungary, 1125
Budapest, Hungary, 1204
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Miskolc, Hungary, 3501
Miskolc, Hungary, 3529
Siofolk, Hungary, 8600
Szeged, Hungary, 6720
Székesfehérvár, Hungary, 8000
Poland
Bydgoszcz, Poland, 85-168
Katowice, Poland, 40-752
Olawa, Poland, 55-200
Szczecin, Poland, 71-252
Wroclaw, Poland, 50-556
Wroclaw, Poland, 51-149
Sponsors and Collaborators
Laboratoires Mayoly Spindler
Investigators
Study Chair: Philippe Ducrotte, M.D

ClinicalTrials.gov Identifier: NCT00542295     History of Changes
Other Study ID Numbers: IMTO601
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008

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