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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00352989 |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 1 Month to 36 Months |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Philippe Garnier, MD | Ipsen |
Study ID Numbers: | 2-31-00250-101 |
Study First Received: | July 13, 2006 |
Last Updated: | September 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00352989 |
Health Authority: | Malaysia: Ministry of Health |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |