BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Colonoscopy Clinical Trial

Official title:

BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856843
• Other study ID #: BLI800-303
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2009
• Last updated: October 15, 2010
• Start date: February 2009

Study information

• Verified date: October 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 evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• 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 indication.

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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

2. Subjects who had previous gastrointestinal surgeries.

3. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

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

6. Subjects undergoing colonoscopy for foreign body removal and decompression.

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 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 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:
• BLI800
Solution for oral administration prior to colonoscopy
• Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy

Locations

Country	Name	City	State
United States	Long Island GI Research Group	Great Neck	New York
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Jupiter Research	Jupiter	Florida
United States	Miami Research Associates	Miami	Florida
United States	University of South Alabama	Mobile	Alabama

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	Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.	2 days	No
Secondary	Assessment of Residual Stool - Cecum	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Stool - Ascending Colon	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Stool - Transverse Colon	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Stool - Descending Colon	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Stool - Sigmoid Colon/Rectum	The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Fluid - Cecum	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Fluid - Ascending Colon	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Fluid - Transverse Colon	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Fluid - Descending Colon	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Assessment of Residual Fluid - Sigmoid Colon/Rectum	The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.	2 days	No
Secondary	Subject Symptom Scores	Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).	2 days	Yes
Secondary	Mean Change in Serum Chemistry (mg/dL)	Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.	up to 15 days	Yes
Secondary	Mean Change in Serum Chemistry (mEq/L)	Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.	up to 15 days	Yes