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Sponsored by: |
Braintree Laboratories |
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Information provided by: | Braintree Laboratories |
ClinicalTrials.gov Identifier: | NCT00583609 |
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.
Condition | Intervention | Phase |
---|---|---|
Constipation |
Drug: PEG3350 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
PEG3350
|
Drug: PEG3350
PEG3350
|
Ages Eligible for Study: | 4 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Little Rock, Arkansas, United States | |
United States, New Jersey | |
Morristown, New Jersey, United States |
Study Director: | John McGowan | Braintree Laboratories, Inc. |
Responsible Party: | Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Manager ) |
Study ID Numbers: | 851-PP-03 |
Study First Received: | December 20, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00583609 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |