NCT05587322

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Braintree Laboratories · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of the Treatment Phase of the study is to evaluate the safety and efficacy of 4 weeks of once daily oral administration of BLI5100 low dose, BLI5100 high dose, or placebo in patients with NERD. The objective of the Extension Phase of the study is to evaluate the safety of extended exposure to once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.

Conditions

• Non-erosive Reflux Disease

Interventions

Type	Name	Description
DRUG	BLI5100	Orally via tablet
DRUG	Placebo	Orally via tablet

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-10-13
• Completion: 2024-04-23
• First posted: 2022-10-20
• Last updated: 2024-07-24

Locations

112 sites across 1 country: United States

Regulatory

• FDA-regulated drug study