Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
1 other identifier
interventional
400
2 countries
18
Brief Summary
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2007
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedOctober 1, 2008
September 1, 2008
1 year
October 10, 2007
September 30, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Subject self assessment of abdominal pain/discomfort
Baseline and 4 weeks
Secondary Outcomes (1)
IBS life impact, overall treatment assessment, concomitant factors
Baseline and 4 weeks
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- male or female ambulatory patients, aged 18-75 years
- with IBS as defined by Rome III criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1106, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Budapest, 1204, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Miskolc, 3501, Hungary
Unknown Facility
Miskolc, 3529, Hungary
Unknown Facility
Siofolk, 8600, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Bydgoszcz, 85-168, Poland
Unknown Facility
Katowice, 40-752, Poland
Unknown Facility
Oława, 55-200, Poland
Unknown Facility
Szczecin, 71-252, Poland
Unknown Facility
Wroclaw, 50-556, Poland
Unknown Facility
Wroclaw, 51-149, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Philippe Ducrotte, M.D
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2008
Study Completion
September 1, 2008
Last Updated
October 1, 2008
Record last verified: 2008-09