NCT04446299 is a Phase 3 clinical trial of Bowel Prep in Colonoscopy, sponsored by Braintree Laboratories.

Who is sponsoring NCT04446299?

NCT04446299 is sponsored by Braintree Laboratories.

What drugs are being tested in NCT04446299?

Interventions in NCT04446299: Bowel Prep.

What condition does NCT04446299 study?

NCT04446299 studies Colonoscopy.

Is NCT04446299 still recruiting?

NCT04446299 is currently completed. Last updated 7 November 2023.

Are results published for NCT04446299?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-07 · How we verify

NCT04446299

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 7 November 2023

What this trial tests

Phase 3 trial testing Bowel Prep in Colonoscopy in 519 participants. Completed in 22 January 2021.

Timeline

13 July 2020

Primary endpoint
22 December 2020

22 January 2021

Quick facts

Lead sponsor	Braintree Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	519
Start date	13 July 2020
Primary completion	22 December 2020
Estimated completion	22 January 2021
Sites	25 locations across United States

Drugs / interventions tested

Bowel Prep — full drug profile →

Conditions studied

Colonoscopy — all drugs for Colonoscopy →

Sponsor

Braintree Laboratories — full company profile →

Who can join

Adults 18 to 85, any sex, with Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Subjects With Successful Bowel Preparation Primary · 2 days

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).

Group	Value	95% CI
BLI4900	215
FDA Approved Control	212

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 1.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BLI4900

Serious: 1/233 (0%)

Deaths: 0/233

FDA Approved Control

Serious: 0/243 (0%)

Deaths: 0/243

Serious adverse events (1 terms)

Reaction	System	BLI4900	FDA Approved Control
COVID-19	Infections and infestations	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	BLI4900	FDA Approved Control
Nausea	Gastrointestinal disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—

Most-reported serious reactions: COVID-19.

Data from ClinicalTrials.gov NCT04446299 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bowel Prep

Trials testing the same drug.

NCT04446312 — Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy · Phase 3 · completed
NCT04238091 — Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata · Phase 2 · withdrawn

Other recruiting trials for Colonoscopy

Currently open trials in the same condition.

NCT07353853 — Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease · NA · recruiting
NCT07335705 — Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients · recruiting
NCT06763705 — Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy · Phase 4 · recruiting
NCT07171853 — The Carbon Footprint Study of Colonoscopy · recruiting
NCT07355777 — Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation · NA · recruiting

Other Braintree Laboratories trials

Trials by the same sponsor.

NCT05890001 — A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease · Phase 3 · completed
NCT05587309 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis · Phase 3 · completed
NCT05587322 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease · Phase 3 · completed
NCT04446312 — Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy · Phase 3 · completed
NCT04214301 — An Open-Label Preference Evaluation of BLI800 · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04446299 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Braintree Laboratories
Last refreshed: 7 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04446299.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing