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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00352989

Purpose

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.

Condition	Intervention	Phase
Diarrhoea	Drug: Smecta (Diosmectite), duration of treatment - 7 days	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Diarrhea

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Cumulative faecal output (g) [ Time Frame: 72 hours after the first study drug intake ]
Faecal output (g/kg of body weight) per day [ Time Frame: 72 hours after the first study drug intake ]
Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance) [ Time Frame: 7 days after the first study drug intake ]
Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline) [ Time Frame: 7 days after the first study drug intake ]
Percentage of body weight gain in comparison with body weight at inclusion [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Till 7 days after first study drug intake ]
Tolerance of Smecta (assessed via adverse event reporting) [ Time Frame: Till 7 days after the last study drug intake ]

Estimated Enrollment:	300
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	1 Month to 36 Months
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352989

Locations

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Philippe Garnier, MD

Ipsen

More Information

No publications provided

Study ID Numbers:	2-31-00250-101
Study First Received:	July 13, 2006
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00352989 History of Changes
Health Authority:	Malaysia: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

Additional relevant MeSH terms:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 03, 2009