Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

Mayoly Spindler

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: anti spasmodic agents; Drug: alverine citrate, simeticone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01404923

FMTO901

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

• Strategy A = MeteoSpasmyl®, on-demand therapy
• Strategy B = standard of care chosen by the physician

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female ambulatory patients, aged >= 18 years
• with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
• with a IBS-SSS between 175 and 400

Exclusion criteria

• Acute diarrhea, bowel disorders due to an underlying cause
• Patient treated with MeteoSpasmyl® within the past 6 months
• Recent history of gastro intestinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

meteospasmyl

Experimental group

Treatment:

Drug: alverine citrate, simeticone

standard of care

Active Comparator group

Treatment:

Drug: anti spasmodic agents