|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Braintree Laboratories |
|---|---|
| Information provided by: | Braintree Laboratories |
| ClinicalTrials.gov Identifier: | NCT00425594 |
Purpose
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: HalfLytely and Bisacodyl Tablets - Formulation 1 Drug: HalfLytely and Bisacodyl Tablets - Formulation 2 Drug: NuLYTELY |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
| Official Title: | A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2007 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile, Alabama, United States, 36604 | |
| Tuscaloosa, Alabama, United States, 35406 | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32610 | |
| Orlando, Florida, United States, 32801 | |
| United States, Illinois | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| Buffalo, New York, United States, 14222 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43205 | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Lancaster, Pennsylvania, United States, 17604 | |
| United States, South Carolina | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Vermont | |
| Burlington, Vermont, United States, 05401 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | John McGowan | Braintree Laboratories, Inc. |
More Information
| Responsible Party: | Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Manager ) |
| Study ID Numbers: | F38-25 |
| Study First Received: | January 19, 2007 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00425594 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
colonoscopy bowel preparation prep |
|
Therapeutic Uses Gastrointestinal Agents Cathartics Bisacodyl Pharmacologic Actions |