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To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HalfLytely with Bisacodyl Tablets Bowel Prep Kit | Drug | |||
| HalfLytely - Reformulation | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - preparation quality using a 4-point scale |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - patient-reported preparation related side-effects |
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Inclusion Criteria:
- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:
Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Goldstein, M.D. | Long Island GI Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
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| Jupiter |
| Florida |
| 33458 |
| United States |
| Miami | Florida | 33173 | United States |
| Baton Rouge | Louisiana | 70809 | United States |
| Laurel | Maryland | 20707 | United States |
| Great Neck | New York | 11023 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Germantown | Tennessee | 38138 | United States |
| Bellevue | Washington | 98004 | United States |
| Spokane | Washington | 99207 | United States |
| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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