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NCT04446299 · ClinicalTrials.gov registry record · Phase 3

Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

A Phase 3 study of Colonoscopy, sponsored by Braintree Laboratories.

Completed
Registry status
Phase 3
Development phase
519
Enrollment target
20
Study locations

NCT04446299: Completed Phase 3 study of Colonoscopy, sponsored by Braintree Laboratories.

NCT04446299 is a Phase 3 study of Colonoscopy that has completed, run by Braintree Laboratories. The registered enrollment target is 519 participants, roughly in line with the 476-participant average among 20 other Colonoscopy trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04446299, a Phase 3 study of Colonoscopy, has completed, sponsored by Braintree Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
519 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).

Conditions Studied

Interventions

  • DRUG Bowel Prep

Study Locations (20)

Florida

  • 301 Research Site 16 - Clearwater
  • 301 Research Site 12 - Jacksonville
  • 301 Research Site 9 - Palm Harbor
  • 301 Research Site 4 - Palmetto Bay
  • 301 Research Site 26 - Port Orange
  • 301 Research Site 14 - St. Petersburg
  • 301 Research Site 25 - Sunrise

New York

  • 301 Research Site 15 - Brooklyn
  • 301 Research Site 5 - Great Neck
  • 301 Research Site 23 - New York

Louisiana

  • 301 Research Site 3 - Monroe
  • 301 Research Site 17 - Shreveport

Alabama

  • 301 Research Site 18 - Huntsville

Arizona

  • 301 Research Site 24 - Sun City

California

  • 301 Research Site 7 - San Diego

Georgia

  • 301 Research Site 2 - Decatur

Indiana

  • 301 Research Site 10 - Indianapolis

Trial Details

FieldValue
Enrollment Target 519 participants
Start Date 2020-07-13
Est. Completion 2021-01-22
Phase Phase 3
Braintree Laboratories

49 total trials

What the finished NCT04446299 record still lists

NCT04446299 is an interventional study that assigns participants to a tested intervention. The registered 519 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 476-participant average among 20 other Colonoscopy trials with a reported enrollment target.

The record links to 1 condition, with Colonoscopy appearing as the primary indexed condition, and to 1 intervention - of which Bowel Prep is the first listed.

NCT04446299 names 20 study sites across 11 states, led by Florida, New York, Louisiana.

Frequently Asked Questions

What is clinical trial NCT04446299 about?

NCT04446299 is a clinical study titled "Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy". 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.

What is the current status of trial NCT04446299?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2020-07-13. Estimated completion is 2021-01-22.

What conditions does trial NCT04446299 study?

This clinical trial studies the following conditions: Colonoscopy.

What interventions are being tested in trial NCT04446299?

The interventions under investigation include: Bowel Prep (DRUG).

Who is sponsoring clinical trial NCT04446299?

This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04446299 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Colonoscopy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04446299's enrollment target sits among peer trials

519 5th of 20 higher than 16 of 20 other Colonoscopy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colonoscopy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04446299, the US trial registry maintained by the National Library of Medicine. NCT04446299 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.