BLI5100 for Acid Reflux

Recruiting at 112 trial locations

Overseen By Leah Hollins

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Braintree Laboratories

Must not be taking: Antipsychotics, Antidepressants, Anxiolytics, others

Disqualifiers: Esophageal stricture, Barrett's esophagus, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

800 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop using gastric acid-suppressive agents, including PPIs, within 2 weeks before the screening endoscopy. You also need to avoid using two or more doses of reflux-related medications like H2 blockers and antacids within 1 week before the screening. If you're on a stable dose of certain medications like prescribed opioids or psychiatric medications, you may continue them if they meet specific criteria.

What data supports the effectiveness of the drug BLI5100 for treating acid reflux?

Research shows that drugs similar to BLI5100, like proton pump inhibitors (PPIs), are effective in treating acid reflux and related conditions by reducing stomach acid, which helps relieve symptoms. ^{1 2 3 4 5}

How does the drug BLI5100 for acid reflux differ from other treatments?

The unique aspect of BLI5100 for acid reflux is not directly detailed in the provided research, but it may offer a novel approach compared to existing treatments like proton pump inhibitors (PPIs) or antacids, which primarily focus on reducing stomach acid. Without specific information on BLI5100's mechanism or formulation, its distinctiveness remains unclear. ^{2 5 6 7 8}

Research Team

Leah Hollins

Principal Investigator

Braintree Laboratories / Sebela Pharmaceuticals

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

Willing and able to provide written informed consent at Screening;

I am either not able to have children or will use birth control during the study.

I have a history of severe acid reflux.

Exclusion Criteria

I haven't taken any acid-reducing medication in the last 2 weeks.

I must continue taking NSAIDs throughout the study.

I have a condition that causes excessive stomach acid.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BLI5100 low dose, BLI5100 high dose, or placebo once daily for 8 weeks

8 weeks

Extension

Participants continue to receive BLI5100 low dose or high dose once daily for 20 weeks

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BLI5100
• Placebo

Trial Overview 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.

Participant Groups

Group I: BLI5100 Low Dose Experimental Treatment 1 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 Dose Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Braintree Laboratories

Lead Sponsor

Trials

49

Recruited

13,500+

Findings from Research

In a meta-analysis of 14 randomized controlled trials involving 771 participants, proton pump inhibitor (PPI) therapy was found to significantly improve reflux symptoms in patients with laryngopharyngeal reflux (LPR) compared to placebo, with a risk difference of 0.15.

While PPI therapy improved the total reflux symptom index, it did not show any significant advantage over placebo in improving the reflux finding score, indicating that while symptoms may improve, some clinical findings may not reflect this change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitor Therapy for the Treatment of Laryngopharyngeal Reflux: A Meta-Analysis of Randomized Controlled Trials. Guo, H., Ma, H., Wang, J.[2016]

In a study of 214 patients with non-erosive gastro-oesophageal reflux disease (GERD), lansoprazole significantly reduced daytime and night-time heartburn compared to placebo, showing effectiveness from the first day of treatment.

Patients taking lansoprazole experienced fewer days and nights with heartburn and less need for antacids over the 8-week treatment period, with a similar safety profile to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis. Richter, JE., Kovacs, TO., Greski-Rose, PA., et al.[2019]

In a double-blind study involving 32 patients with chronic heartburn, both liquid antacid and placebo showed significant improvements in the frequency and severity of heartburn, indicating that the natural history of reflux esophagitis tends to improve over time regardless of treatment.

There was no significant difference in the effectiveness of antacid compared to placebo in healing esophagitis or reducing painful episodes, suggesting that the perceived benefits of antacids may be due to a placebo effect rather than a direct therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. Graham, DY., Patterson, DJ.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Short-term treatment of gastroesophageal reflux disease. [2019]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The Therapeutic and Diagnostic Value of 2-week High Dose Proton Pump Inhibitor Treatment in Overlapping Non-erosive Gastroesophageal Reflux Disease and Functional Dyspepsia Patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitor Therapy for the Treatment of Laryngopharyngeal Reflux: A Meta-Analysis of Randomized Controlled Trials. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Famotidine in Preventing Heartburn and Related Symptoms of Upper Gastrointestinal Discomfort. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Lower esophageal sphincter injections for the treatment of gastroesophageal reflux disease. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. [2019]