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Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

NCT04446312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-10-27

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Conditions

  • Colonoscopy

Interventions

DRUG

Bowel Prep

Orally ingested liquid bowel preparation

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • John McGowan · Braintree Laboratories / Sebela Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-01-07
Completion
2021-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446312 on ClinicalTrials.gov