Text Size

Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier:
NCT00542295
First received: October 10, 2007
Last updated: September 30, 2008
Last verified: September 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: alverine citrate and simeticone
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Simethicone
U.S. FDA Resources

Further study details as provided by Laboratoires Mayoly Spindler:

Primary Outcome Measures:
  • Subject self assessment of abdominal pain/discomfort [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IBS life impact, overall treatment assessment, concomitant factors [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: alverine citrate and simeticone
Other Name: Meteospasmyl®
Placebo Comparator: B Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542295

Locations
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1125
Budapest, Hungary, 1106
Budapest, Hungary, 1204
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Miskolc, Hungary, 3529
Miskolc, Hungary, 3501
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, 51-149
Wroclaw, Poland, 50-556
Sponsors and Collaborators
Laboratoires Mayoly Spindler
Investigators
Study Chair: Philippe Ducrotte, M.D
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00542295     History of Changes
Other Study ID Numbers: IMTO601
Study First Received: October 10, 2007
Last Updated: September 30, 2008
Health Authority: Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Simethicone
Alverine
Mebeverine
Emollients
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013