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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HalfLytely and Bisacodyl Tablets - Formulation 1 | Drug | |||
| HalfLytely and Bisacodyl Tablets - Formulation 2 | Drug | |||
| NuLYTELY | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - preparation quality using a 4-point scale |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry. |
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Inclusion Criteria:
Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
Between 6 and 16 years of age at screening.
Otherwise in good health, as determined by physical exam and medical history.
If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse).
Negative urine pregnancy test at screening, if applicable
In the investigator's judgment, parent/guardian is mentally competent to provide informed consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
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| Mobile |
| Alabama |
| 36604 |
| United States |
| Tuscaloosa | Alabama | 35406 | United States |
| Phoenix | Arizona | 85016 | United States |
| Little Rock | Arkansas | 72202 | United States |
| San Francisco | California | 94143 | United States |
| Gainesville | Florida | 32610 | United States |
| Orlando | Florida | 32801 | United States |
| Park Ridge | Illinois | 60068 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Boston | Massachusetts | 02114 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Jackson | Mississippi | 39216 | United States |
| Omaha | Nebraska | 68198 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Morristown | New Jersey | 07962 | United States |
| Buffalo | New York | 14222 | United States |
| Cleveland | Ohio | 44106 | United States |
| Columbus | Ohio | 43205 | United States |
| Lancaster | Pennsylvania | 17604 | United States |
| Columbia | South Carolina | 29203 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | 76508 | United States |
| Salt Lake City | Utah | 84113 | United States |
| Burlington | Vermont | 05401 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| C000595212 | polyethylene glycol 3350 |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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