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

Phase 3

Completed

• Conditions: Diarrhoea

• Registration Number: NCT00352989
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Primary Completion: 2007-03-24
• Study Completion: 2007-03-24
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 302

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative faecal output (g/kg of body weight)	72 hours after first study drug intake

Secondary Outcome Measures

Name	Time	Method
Tolerance of Smecta (assessed via adverse event reporting)	Till 7 days after the last 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
Faecal output (g/kg of body weight) per day	72 hours after the first study drug intake
Cumulative faecal output (g)	72 hours 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Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)	7 days after the first study drug intake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

Trial Locations

Locations (19)

Kulim Hospital; 🇲🇾 Jalan Mahang, Kedah, Malaysia

Serdang Hospital; 🇲🇾 Selangor, Malaysia

Ipoh Hospital; 🇲🇾 Ipoh - Perak, Malaysia

Tengku Ampuan Rahimah Hospital; 🇲🇾 Selangor, Malaysia

Tuanku Jaafar Hospital; 🇲🇾 Negeri Sembilan, Malaysia

Pulau Pinang Hospital; 🇲🇾 Pulau Pinang, Malaysia

Sungai Petani Hospital; 🇲🇾 Sungai Petani, Malaysia

Teluk Intan Hospital; 🇲🇾 Teluk Intan, Perak, Malaysia

Alor Setar Hospital; 🇲🇾 Alor Setar Kedah, Malaysia

Kuala Terengganu Hospital; 🇲🇾 Kuala Terengganu, Malaysia

Tengku Ampuan Afzan Hospital; 🇲🇾 Kuantan Pahang, Malaysia

Sarawak General Hospital; 🇲🇾 Kuching, Malaysia

Taiping Hospital; 🇲🇾 Taiping Perak, Malaysia

Kajang Hospital; 🇲🇾 Jalan Semenyih, Kajang, Malaysia

Seri Manjung Hospital; 🇲🇾 Seri Manjung, Perak, Malaysia

Temerloh Hospital; 🇲🇾 Hospital Sultan Haji Ahmad Shah, Pahang, Malaysia

Raja Perempuan Zainab II Hospital; 🇲🇾 Kelantan, Malaysia

Kluang Hospital; 🇲🇾 Kluang, Johor, Malaysia

Malacca Hospital; 🇲🇾 Melaka, Malaysia