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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 belowSelect...
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:Select...
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
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
Find a Location
Who is running the clinical trial?
Braintree LaboratoriesLead Sponsor
48 Previous Clinical Trials
12,724 Total Patients Enrolled
1 Trials studying Non-erosive Reflux Disease
400 Patients Enrolled for Non-erosive Reflux Disease
Leah HollinsStudy DirectorBraintree Laboratories / Sebela Pharmaceuticals
1 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any acid-reducing medication in the last 2 weeks.I am 18 years old or older.I must continue taking NSAIDs throughout the study.I am either not able to have children or will use birth control during the study.I have a condition that causes excessive stomach acid.I am 18 years old or older.You have a history of allergic reactions or are intolerant to the active ingredient or other ingredients in the study drug.I have a history of severe acid reflux.I agree to use birth control from the start of the study until 3 months after the last dose.I understand and can follow the study's requirements.I agree not to donate sperm for 3 months after my last dose of the study drug.You have a history of mental health conditions like bipolar disorder, anxiety disorder, panic disorder, or other psychological disorders.I have a history of severe acid reflux.I have been on a stable dose of mental health or sleeping medication for over 6 months.I was diagnosed with a serious stomach or esophagus issue in the last 2 months.I cannot have children due to surgery or menopause, or I agree to use birth control during the study.I've had heartburn on 4 or more days in a week recently.I have had heartburn for at least 6 months.I haven't had severe swallowing issues, bleeding, weight loss, anemia, or bloody stools in the last month, or these symptoms have been checked and are not due to cancer.I have issues like strictures, bleeding, or ulcers in my upper GI tract.I haven't had cancer in the past 5 years, except for treated skin cancer.I have taken 2 or more doses of acid reflux medication in the week before my upper GI endoscopy.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I agree to use birth control from the start of the study until 3 months after the last dose.I agree not to donate sperm for 3 months after my last dose of the study drug.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've experienced heartburn on 4 or more days in a week recently.I have or might have a digestive system disorder.I understand and can follow the study's requirements.I cannot have an upper GI endoscopy.I have had heartburn for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: BLI5100 High Dose
- Group 2: Placebo
- Group 3: BLI5100 Low Dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-erosive Reflux Disease Patient Testimony for trial: Trial Name: NCT05587322 — Phase 3