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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857272
• Other study ID #: F38-27
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2009
• Last updated: September 29, 2010
• Start date: February 2009

Study information

• Verified date: September 2010
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:

2. At least 18 years of age

3. Otherwise in good health, as determined by physical exam and medical history

4. If female, and of child-bearing potential, is using an acceptable form of birth control

5. Negative urine pregnancy test at screening, if applicable

6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon

2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration

3. Subjects who are undergoing colonoscopy for foreign body removal and decompression

4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics

5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics

6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia

7. Subjects who are pregnant or lactating, or intending to become pregnant during the study

8. Subjects of childbearing potential who refuse a pregnancy test

9. Subjects who are allergic to any preparation components

10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures

11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• PEG electrolyte lavage solution + bisacodyl - reformulation
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
• PEG electrolyte lavage solution + bisacodyl
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Franklin Gastroenterology	Franklin	Tennessee
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	United Medical Research	New Smyrna Beach	Florida
United States	Advanced Clinical Research Institute	Orange	California
United States	Medical Associates Research Group	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No