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Long-Term Safety of 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
Be older than 18 years old
Must not have
Requirement of persistent use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study
If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days after the last dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial tests the safety of taking a drug daily for up to a year to treat acid reflux and healed esophagitis.
Who is the study for?
This trial is for patients with non-erosive reflux disease or healed erosive esophagitis who completed prior BLI5100 studies without serious issues. Participants must not be pregnant, use reliable birth control, and avoid certain medications like NSAIDs and antipsychotics.
What is being tested?
The study tests the long-term safety of a daily oral medication called BLI5100 over a year. It's for those who've had acid reflux or esophagitis but are now in better condition after previous treatment.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to BLI5100 during the trial to assess its long-term safety profile.
Eligibility Criteria
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.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Select...
My liver and kidney function tests show significant abnormalities.
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: BLI5100 Low DoseExperimental Treatment1 Intervention
Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.
Group II: BLI5100 High DoseExperimental Treatment1 Intervention
Patients will take BLI5100 High Dose once daily, orally, for up to 29 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
13,124 Total Patients Enrolled
1 Trials studying Non-erosive Reflux Disease
800 Patients Enrolled for Non-erosive Reflux Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I must continue taking NSAIDs throughout the study.I agree not to donate sperm for 3 months after my last dose of the study drug.I agree to use birth control from the start of the study until 3 months after the last dose.I am on a stable dose of mental health or sleeping medication.My liver and kidney function tests show significant abnormalities.I understand and can follow the study's requirements.I am not able to have children or I agree to use birth control during the study.You have had alcoholism or substance abuse/addiction within the last year before joining the BLI5100-301 and BLI5100-302 studies.You have a mental health condition like bipolar disorder, anxiety disorder, panic disorder, or other psychological disorders.I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Research Study Groups:
This trial has the following groups:- Group 1: BLI5100 Low Dose
- Group 2: BLI5100 High Dose
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.