A Safety Study of 3 Different Bowel Cleansing Preparations

Braintree Laboratories

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation; Colonoscopy; Endoscopy

Treatments: Drug: PEG-3350 based bowel preparation; Drug: BLI800 investigational preparation regimen; Drug: BLI800 approved preparation regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01501513

BLI800-440

Details and patient eligibility

About

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Enrollment: 541 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
• At least 18 years of age
• 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
• Subjects with severe liver or renal insufficiency.
• Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects undergoing colonoscopy for foreign body removal and decompression.
• Subjects who are pregnant or lactating, or intending to become pregnant during the study.
• Subjects of childbearing potential who refuse a pregnancy test.
• Subjects 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 surgical, drug, or device study within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

541 participants in 3 patient groups

BLI800 approved preparation regimen

Experimental group

Description:

BLI800 approved preparation regimen

Treatment:

Drug: BLI800 approved preparation regimen

BLI800 investigational preparation regimen

Experimental group

Description:

BLI800 investigational preparation regimen

Treatment:

Drug: BLI800 investigational preparation regimen

PEG-3350 based bowel preparation

Active Comparator group

Description:

PEG-3350 based bowel preparation

Treatment:

Drug: PEG-3350 based bowel preparation