Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults

Ipsen

Status and phase: Completed; Phase 4

Conditions: Diarrhea

Treatments: Drug: Diosmectite (Smecta®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276328

2-31-00250-009

Details and patient eligibility

About

The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.

Enrollment: 346 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less
• Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day

Exclusion criteria

• Gross blood, pus in the stools
• Fever >39ºC
• Other episode of acute watery diarrhoea within the last 30 days
• History of chronic diarrhoea or motor diarrhoea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind