A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Colonoscopy Clinical Trial

Official title:

A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023085
• Other study ID #: BLI4700-201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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

2. Have previously had a colonoscopy performed

3. At least 18 years of age

4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)

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

6. Negative urine pregnancy test at screening, if applicable

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

Key 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 significant gastrointestinal surgeries.

3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

4. Subjects with a prior history of renal, liver or cardiac insufficiency

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

6. Subjects undergoing colonoscopy for foreign body removal and/or 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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI4700
BLI4700 bowel preparation

Locations

Country	Name	City	State
United States	Braintree Research Site 1	Anaheim	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	Number and Percentage of Subjects With Successful Bowel Cleansing	% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)	Day of colonoscopy