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BLI5100 for Acid Reflux

Phase 3

Waitlist Available

Research Sponsored by Braintree Laboratories

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥18 years at the time of signing informed consent

Have documented history of symptomatic GERD

Must not have

Requirement of persistent use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study

Presence of any gastric acid hypersecretory conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed but may include typical drug reactions such as digestive issues, allergic responses, headaches, fatigue or other symptoms based on the individual's reaction to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a history of severe acid reflux.

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I have a history of severe acid reflux.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I must continue taking NSAIDs throughout the study.

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I have a condition that causes excessive stomach acid.

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

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

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

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

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I have or might have a digestive system disorder.

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I cannot have an upper GI endoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BLI5100

2022

Completed Phase 3

~800

0 / 13Eligibility criteria met