A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
Overview
- Phase
- Phase 3
- Intervention
- BLI5100
- Conditions
- Non-erosive Reflux Disease
- Sponsor
- Braintree Laboratories
- Enrollment
- 800
- Locations
- 112
- Primary Endpoint
- Percentage of 24-hour heartburn-free days
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥18 years at the time of signing informed consent;
- •Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;
- •Have documented history of symptomatic GERD;
- •Have no mucosal break(s) on the upper GI endoscopy performed during Screening;
- •Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;
- •Able to understand and comply with the protocol requirements;
- •Willing and able to provide written informed consent at Screening;
- •A female of reproductive potential defined as a non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure; or If a female of childbearing potential, agrees to use an acceptable form of birth control and avoid egg donation from the Screening Visit until 6 months after the last dose of study drug.
- •If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug.
- •If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.
Exclusion Criteria
- •Unable to undergo an upper GI endoscopy;
- •Presence of esophageal stricture, gastroesophageal varix (including post sclerotherapy or ligation), untreated Barrett's esophagus, gastric bleeding, infection, tumor, or gastric or duodenal ulcer on the upper GI endoscopy;
- •o Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
- •Diagnosed with erosive gastroesophageal reflux disease, acute upper GI bleeding, gastric ulcer or duodenal ulcer, or acute gastritis within 2 months prior to the upper GI endoscopy;
- •Alarm symptoms such as odynophagia, severe dysphagia, upper GI bleeding, weight loss, anemia, or hematochezia within 4 weeks prior to Screening, unless the presumed malignancy is ruled out;
- •History or suspicion of functional upper gastrointestinal disorders, such as:
- •Functional heartburn, as described in the Rome IV criteria, or
- •Functional dyspepsia, as described in the Rome IV criteria.
- •History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease, or documented history of delayed gastric emptying;
- •History of acid-suppressive, esophageal, or gastric surgery;
Arms & Interventions
BLI5100 Low Dose
During the Treatment Period, patients will take BLI5100 low dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 low dose once daily, orally, for 20 weeks.
Intervention: BLI5100
BLI5100 High Dose
During the Treatment Period, patients will take BLI5100 high dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 high dose once daily, orally, for 20 weeks.
Intervention: BLI5100
Placebo
During the Treatment Period, patients will take placebo once daily, orally, for 8 weeks. In the Extension Phase, patients who received placebo in the Treatment Phase will be re-randomized to receive either BLI5100 low dose or BLI5100 high dose to take once daily, orally, for 20 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of 24-hour heartburn-free days
Time Frame: 4 Weeks
Secondary Outcomes
- Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)(4 Weeks)