Phase 4
N=308
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT00857272 ↗Enrolled (actual)
308
Serious AEs
0.3%
Results posted
Sep 2010
Primary outcome: Primary: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale — 77.6; 80.1 percent of participants — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PEG electrolyte lavage solution + bisacodyl - reformulation (Drug); PEG electrolyte lavage solution + bisacodyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale |
77.6; 80.1 | 0.005 sig |
Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
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
Data sourced from ClinicalTrials.gov (NCT00857272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.