CompletedPhase 3

A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease

United States400 participantsStarted 2023-04-05

Plain-language summary

The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have completed the BLI5100-301 or BLI5100-302 study with no serious AE (SAE) related to study drug and no major Protocol Deviations;
. Able to understand and comply with the protocol requirements;
. Willing and able to provide written informed consent at Screening;
. Is a female of non-childbearing potential, or If a female of childbearing potential, agrees to use an acceptable form of birth control and avoid egg donation from the Screening Visit until 6 months after the last dose of study drug;
. If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug;
. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug;
. Have documented healed EE (BLI5100-301 study patients only).

Exclusion criteria

. History of alcoholism, or substance abuse/addiction in the year before enrollment in the BLI5100-301 and BLI5100-302 studies;
. A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is exclusionary, unless the patient is asymptomatic and well-controlled. Stable treatment, including non-medical therapy, is preferred, but minor adjustments can be made and should be consulted with the Medical Monitor;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of treatment-emergent adverse events

Timeframe: 31 Weeks

Trial details

NCT IDNCT05890001

SponsorBraintree Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Non-erosive Reflux Disease trials