F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

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

Official Title
-----------------
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: PEG electrolyte lavage solution + bisacodyl - reformulation
* Drug: PEG electrolyte lavage solution + bisacodyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications: 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 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HalfLytely with 10mg bisacodyl<br>Active control | Drug: PEG electrolyte lavage solution + bisacodyl<br>* multi dose preparation (tablet/solution) for oral administration prior to colonoscopy<br>|
| Experimental: HalfLytely with 5mg bisacodyl<br>Investigational dose | Drug: PEG electrolyte lavage solution + bisacodyl - reformulation<br>* multi dose formulation (tablet/solution) for oral administration prior to colonoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = excellent (no more than small bits of adherent feces/fluid); 3 = good (small amounts of feces or fluid not interfering with the exam); 2 = fair (enough feces or fluid to prevent a completely reliable exam); 1 = poor (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a success and grades of 2 or 1 were considered a failure. | during colonoscopy | 

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