Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome Without Diarrhea

Treatments: Drug: Probiotics (Medirac); Drug: Probiotics (Medirac) placebo/mosapride placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505777

HM-MEMO-201

Details and patient eligibility

About

The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
• Signed informed consent

Exclusion criteria

• IBS-D
• evidence of cathartic colon or history laxative abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 5 patient groups, including a placebo group

Probiotics(Medirac) 10/mosapride 10mg

Experimental group

Treatment:

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Probiotics(Medirac) 15/mosapride 10mg

Experimental group

Treatment:

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Probiotics(Medirac) 15/mosapride 15mg

Experimental group

Treatment:

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Probiotics(Medirac) 30/mosapride 15mg

Experimental group

Treatment:

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Drug: Probiotics (Medirac)

Probiotics(Medirac) placebo/mosapride placebo

Placebo Comparator group

Treatment:

Drug: Probiotics (Medirac) placebo/mosapride placebo