Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Mayoly Spindler

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: alverine citrate and simeticone; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542295

IMTO601

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: alverine citrate and simeticone

B

Placebo Comparator group

Treatment:

Drug: placebo