An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Study Overview
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Brief Summary
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To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Detailed Description
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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.

Official Title
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An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit
* Drug: HalfLytely - Reformulation


Participation Criteria
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Eligibility Criteria
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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 At least 18 years of age 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, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon Subjects with impaired consciousness that predisposes them to pulmonary aspiration Subjects who are undergoing colonoscopy for foreign body removal and decompression 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 Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit|nan|
|Drug: HalfLytely - Reformulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - preparation quality using a 4-point scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - patient-reported preparation related side-effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, preparation