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

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ClinicalTrials.gov Identifier: NCT00276328
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Diosmectite (Smecta®) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.
Study Start Date : January 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276328


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00276328    
Other Study ID Numbers: 2-31-00250-009
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive