Erosive Esophagitis and Non-Erosive Esophagitis

Last updated: November 29, 2023
Sponsor: Braintree Laboratories, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Non-erosive Reflux Disease (Nerd)

Heartburn

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

TX322047
BLI5100-301 & 302
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Upon signing the Pre-screening Informed Consent Form, patients will be scheduled for an Upper GI Endoscopy to determine Erosive or Non-Erosive Esophagitis. Once the results are determined the patient will be placed in the prospective study.

Eligibility Criteria

Inclusion

Inclusion Criteria

The population for this study is patients aged 18 years or older who have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening, and who have no mucosal break(s) on the upper gastrointestinal (GI) endoscopy performed during Pre-Screening.

Study Design

Study Start date:
October 01, 2023
Estimated Completion Date:

Study Description

Erosive Esophagitis Study - This is a Phase 3, double-blind, randomized, 2-phase, active-controlled study to evaluate the efficacy and safety of an investigational product in patients with EE. The first phase (Healing Phase) consists of a Screening Period of up to 28 days, a Treatment Period of up to 8 weeks, and a Follow-Up Visit 14 days after the last dose of study drug for patients who do not move to the Maintenance Phase. The second phase (Maintenance Phase) consists of a Treatment Period of 24 weeks and a Follow-Up Visit 14 days after the last dose of study drug. Non-Erosive Esophagitis Study -This is a Phase 3, double-blind, randomized, placebo-controlled, multi-dose study to evaluate the efficacy and safety of an investigational product in patients with NERD. The study consists of a Screening Period of up to 28 days, a Treatment Phase of 8 weeks, an Extension Phase of 20 weeks, and a Follow-Up Contact 14 days after the last dose of study drug. Individual patient participation for the entire study will last up to 34 weeks.

Connect with a study center

  • Elite Clinical Studies, LLC

    Phoenix, AZ 85018
    United States

    Active - Recruiting

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