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Completed

NCT Number: NCT00276328

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

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.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cabinet Medical, 17 Boulevard Bir Anzaran, Casablanca, Morocco

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diosmectite (Smecta®)

Drug

Primary outcomes

  1. Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool)

Secondary outcomes

  1. Time (hours) from first sachet intake to the last watery stool

  2. Number of stools and number of watery stools per 12 hour period

  3. % of patients with recovery, per 12 hour period

  4. % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period

  5. Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.

Important dates

Study start
2005
Study completion
2006
First posted
Jan 13, 2006
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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