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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diarrhoea
• Intervention / Treatment: Drug: Smecta (Diosmectite), duration of treatment - 7 days

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Alor Setar Kedah, Malaysia, 05100
    • Alor Setar Hospital
  • Ipoh - Perak, Malaysia, 30990
    • Ipoh Hospital
  • Kelantan, Malaysia, 15000
    • Raja Perempuan Zainab II Hospital
  • Kuala Terengganu, Malaysia, 20400
    • Kuala Terengganu Hospital
  • Kuantan Pahang, Malaysia, 25100
    • Tengku Ampuan Afzan Hospital
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Melaka, Malaysia, 75400
    • Malacca Hospital
  • Negeri Sembilan, Malaysia, 70300
    • Tuanku Jaafar Hospital
  • Pulau Pinang, Malaysia, 10450
    • Pulau Pinang Hospital
  • Selangor, Malaysia, 41200
    • Tengku Ampuan Rahimah Hospital
  • Selangor, Malaysia, 43300
    • Serdang Hospital
  • Sungai Petani, Malaysia, 08000
    • Sungai Petani Hospital
  • Taiping Perak, Malaysia, 34000
    • Taiping Hospital
  • Johor
    • Kluang, Johor, Malaysia, 86000
      • Kluang Hospital
  • Kajang
    • Jalan Semenyih, Kajang, Malaysia, 43000
      • Kajang Hospital
  • Kedah
    • Jalan Mahang, Kedah, Malaysia, 09000
      • Kulim Hospital
  • Pahang
    • Hospital Sultan Haji Ahmad Shah, Pahang, Malaysia, 28000
      • Temerloh Hospital
  • Perak
    • Seri Manjung, Perak, Malaysia, 28000
      • Seri Manjung Hospital
    • Teluk Intan, Perak, Malaysia, 36000
      • Teluk Intan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative faecal output (g/kg of body weight)	72 hours after first study drug intake

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative faecal output (g)	72 hours after the first study drug intake
Faecal output (g/kg of body weight) per day	72 hours after the first study drug intake
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)	7 days after the first study drug intake
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)	7 days after the first study drug intake
Percentage of body weight gain in comparison with body weight at inclusion	Till 7 days after the first study drug intake
Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)	Till 7 days after first study drug intake
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	Till 7 days after first study drug intake
Tolerance of Smecta (assessed via adverse event reporting)	Till 7 days after the last study drug intake

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 24, 2007
• Study Completion (Actual): March 24, 2007

Study Registration Dates

• First Submitted: July 13, 2006
• First Submitted That Met QC Criteria: July 14, 2006
• First Posted (Estimate): July 17, 2006

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 2-31-00250-101