BLI5100 for Acid Reflux

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Braintree Laboratories

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new medication called BLI5100 in low and high doses for patients with Non-Erosive Reflux Disease (NERD). It aims to see if BLI5100 is safe and effective in reducing acid reflux symptoms.

Eligibility Criteria

Adults with Non-erosive Reflux Disease (NERD) who've had heartburn for at least 6 months, no esophageal damage on endoscopy, and not using certain medications. Men must use birth control or abstain from sperm donation for 3 months post-trial; women must be non-childbearing or use birth control.

Inclusion Criteria

I am 18 years old or older.

I have a history of severe acid reflux.

I've had heartburn on 4 or more days in a week recently.

I've experienced heartburn on 4 or more days in a week recently.

Exclusion Criteria

I must continue taking NSAIDs throughout the study.

I have a condition that causes excessive stomach acid.

I have issues like strictures, bleeding, or ulcers in my upper GI tract.

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I have had surgery related to acid reflux or on my esophagus/stomach.

I have a history of connective tissue disorder with GI symptoms or inflammatory bowel disease.

I have or might have a digestive system disorder.

I cannot have an upper GI endoscopy.

Treatment Details

The trial tests BLI5100's safety and effectiveness in treating NERD over four weeks compared to a placebo. Participants will receive either a low dose, high dose of BLI5100, or a placebo once daily. There's also an extension phase to assess long-term safety.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BLI5100 Low DoseExperimental Treatment1 Intervention

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.

Group II: BLI5100 High DoseExperimental Treatment1 Intervention

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.

Group III: PlaceboPlacebo Group1 Intervention

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.