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| Sponsor: | Braintree Laboratories |
|---|---|
| Information provided by: | Braintree Laboratories |
| ClinicalTrials.gov Identifier: | NCT00319670 |
Purpose
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Drug: MiraLax |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2006 |
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Ohio | |
| Youngstown, Ohio, United States, 44514 | |
| Principal Investigator: | Samuel Nurko, MD | Children's Hospital Boston |
More Information
| Study ID Numbers: | 851-201 |
| Study First Received: | April 27, 2006 |
| Last Updated: | June 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00319670 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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constipation pediatric |
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Signs and Symptoms Signs and Symptoms, Digestive Constipation |