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Sponsored by: |
Braintree Laboratories |
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Information provided by: | Braintree Laboratories |
ClinicalTrials.gov Identifier: | NCT00153114 |
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
Condition | Intervention | Phase |
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Constipation |
Drug: polyethyleneglycol3350 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | PolyethyleneGlycol3350 Laxative Vs Placebo in Constipated Children |
Ages Eligible for Study: | 4 Years to 16 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
Morristown, New Jersey, United States, 07962 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Samuel Nurko, MD | Children's Hospital Boston |
Study ID Numbers: | 851-15 |
Study First Received: | September 7, 2005 |
Last Updated: | September 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00153114 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Laxatives Signs and Symptoms, Digestive Constipation Cathartics |
Signs and Symptoms Laxatives Signs and Symptoms, Digestive Therapeutic Uses |
Gastrointestinal Agents Constipation Pharmacologic Actions |