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Completed

NCT Number: NCT00352989

Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.

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Key information

Conditions

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

Age range

1 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Kluang Hospital, Kluang, Johor, Malaysia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male
  • acute watery diarrhoea defined as at least 3 watery stools per 24 hours
  • duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
  • dehydration signs requiring oral rehydration according to current WHO guidelines

Exclusion criteria

  • severe dehydration that needs IV therapy
  • presence of gross blood in stools
  • fever >39 degrees Celsius

Treatment and study plan

Smecta (Diosmectite), duration of treatment - 7 days

Drug

Primary outcomes

  1. Cumulative faecal output (g/kg of body weight)

    Time frame: 72 hours after first study drug intake

Secondary outcomes

  1. Cumulative faecal output (g)

    Time frame: 72 hours after the first study drug intake

  2. Faecal output (g/kg of body weight) per day

    Time frame: 72 hours after the first study drug intake

  3. Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)

    Time frame: 7 days after the first study drug intake

  4. Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)

    Time frame: 7 days after the first study drug intake

  5. Percentage of body weight gain in comparison with body weight at inclusion

    Time frame: Till 7 days after the first study drug intake

  6. Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)

    Time frame: Till 7 days after first study drug intake

  7. Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale

    Time frame: Till 7 days after first study drug intake

  8. Tolerance of Smecta (assessed via adverse event reporting)

    Time frame: Till 7 days after the last study drug intake

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Efficacy of Diosmectite (SMECTA®) in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children. A Phase IIIB, Placebo Controlled, Randomized, Double Blind, Parallel Groups, Multicenter Study.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 17, 2006
Registry last updated
Nov 22, 2019

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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