F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
This study has been completed.
Sponsor:
Braintree Laboratories
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00857272
First received: March 5, 2009
Last updated: September 29, 2010
Last verified: September 2010
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Purpose
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: PEG electrolyte lavage solution + bisacodyl - reformulation Drug: PEG electrolyte lavage solution + bisacodyl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Braintree Laboratories:
Primary Outcome Measures:
- Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale [ Time Frame: during colonoscopy ] [ Designated as safety issue: No ]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".
| Enrollment: | 308 |
| Study Start Date: | February 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: HalfLytely with 10mg bisacodyl
Active control
|
Drug: PEG electrolyte lavage solution + bisacodyl
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
|
|
Experimental: HalfLytely with 5mg bisacodyl
Investigational dose
|
Drug: PEG electrolyte lavage solution + bisacodyl - reformulation
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857272
Locations
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Advanced Clinical Research Institute | |
| Orange, California, United States, 92869 | |
| Medical Associates Research Group | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| United Medical Research | |
| New Smyrna Beach, Florida, United States, 32168 | |
| United States, Maryland | |
| Maryland Digestive Disease Research | |
| Laurel, Maryland, United States, 20707 | |
| United States, Tennessee | |
| Franklin Gastroenterology | |
| Franklin, Tennessee, United States, 37067 | |
Sponsors and Collaborators
Braintree Laboratories
Investigators
| Study Director: | John McGowan, MPH | Braintree Laboratories, Inc. |
More Information
No publications provided
| Responsible Party: | John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00857272 History of Changes |
| Other Study ID Numbers: | F38-27 |
| Study First Received: | March 5, 2009 |
| Results First Received: | August 9, 2010 |
| Last Updated: | September 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Braintree Laboratories:
|
colonoscopy bowel preparation |
Additional relevant MeSH terms:
|
Bisacodyl Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013