| January 19, 2007 |
| December 20, 2007 |
| January 2007 |
| May 2007 (final data collection date for primary outcome measure) |
| Efficacy - preparation quality using a 4-point scale |
| Same as current |
| Complete list of historical versions of study NCT00425594 on ClinicalTrials.gov Archive Site |
| Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry. |
| Same as current |
| |
| A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population |
| A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
| Colonoscopy |
- Drug: HalfLytely and Bisacodyl Tablets - Formulation 1
- Drug: HalfLytely and Bisacodyl Tablets - Formulation 2
- Drug: NuLYTELY
|
| |
| |
| |
| Completed |
| 150 |
| May 2007 |
| May 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
- Subjects impacted at screening
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal and decompression
- Subjects with known difficulties for swallowing tablets
- Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics.
- Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics.
- Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
- Subjects who are pregnant or lactating, or intending to become pregnant during the study.
- Subjects of childbearing potential who refuse a pregnancy test.
- Subjects who are allergic to any preparation components
- Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
- Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
|
| Both |
| 6 Years to 16 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00425594 |
| John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. |
| F38-25 |
| Braintree Laboratories |
|
| Study Director: |
John McGowan |
Braintree Laboratories, Inc. |
|
|
| Braintree Laboratories |
| December 2007 |