Non-erosive Reflux DiseasePhase 3NCT05890001
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
A Phase 3 study testing BLI5100 in people with Non-erosive Reflux Disease and Erosive Esophagitis, run by Braintree Laboratories at 60 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-erosive Reflux Disease, Erosive Esophagitis
- What is being tested?
- BLI5100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 60 sitesUnited States
- Study dates
- 5 Apr 2023to 8 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- History of alcoholism, or substance abuse/addiction in the year before enrollment in the BLI5100-301 and BLI5100-302 studies;
- Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies.
- Note: Retesting of a positive urine drug screen requires Medical Monitor approval. Positive urine drug screen for all drugs will require verification of prescription for the positive tested substance.
- 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;
- Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies;
- Requirement of persistent (>3 times per week for >30 days) use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study;
Show all 16Show fewer
- o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation.
- If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug;
- Abnormal laboratory results with clinical relevance at Screening as follows:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase level of ≥2 × upper limit of normal (ULN);
- Total bilirubin level of ≥2 × ULN, unless Gilbert's syndrome is confirmed when direct bilirubin is ≤0.3 mg/dL;
- Estimated glomerular filtration rate <30 mL/min.
- Note: A lab value obtained during the Screening period may be retested once with Medical Monitor approval.
- Abnormal ECG of clinical significance;
- Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) within 4 weeks of initiation of study drug;
- Any other clinically relevant condition that would confound study endpoints or adversely affect patient compliance with the study procedures in the medical judgment of the Investigator or Medical Monitor based on previous medical history or findings on Screening assessments.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Research Site 100
Bellaire, Texas, 77401
Research Site 35
Brooklyn, New York, 11235
Research Site 111
Chesterfield, Missouri, 63005
Research Site 94
Chula Vista, California, 91910
Research Site 20
Columbus, Ohio, 43213
Research Site 88
Columbus, Ohio, 43215
Research Site 108
Cooper City, Florida, 33024
Research Site 98
Dallas, Texas, 75230
Research Site 91
Doral, Florida, 33172
Research Site 75
Fayetteville, North Carolina, 28304
Research Site 99
Forney, Texas, 75126
Research Site 07
Great Neck, New York, 11023
Research Site 01
Gurnee, Illinois, 60031
Research Site 28
Hartsdale, New York, 10530
Research Site 78
Homestead, Florida, 33030
Research Site 45
Houma, Louisiana, 70363
Research Site 10
Huntington Park, California, 90255
Research Site 24
Huntsville, Alabama, 35801
Research Site 55
La Mesa, California, 91942
Research Site 06
Las Vegas, Nevada, 89106
Research Site 29
Lewisville, Texas, 75057
Research Site 87
Little Rock, Arkansas, 72211
Research Site 72
Los Angeles, California, 90017
Research Site 54
Los Angeles, California, 90057
Research Site 23
Maitland, Florida, 32751
Research Site 12
Marrero, Louisiana, 70072
Research Site 109
Mentor, Ohio, 44060
Research Site 48
Metairie, Louisiana, 70006
Research Site 38
Miami, Florida, 33134
Research Site 43
Miami, Florida, 33136
Research Site 67
Miami, Florida, 33155
Research Site 92
Miami, Florida, 33173
Research Site 71
Miami, Florida, 33186
Research Site 42
Miami Lakes, Florida, 33014
Research Site 60
Nashville, Tennessee, 37203
Research Site 103
Nashville, Tennessee, 37211
Research Site 34
New Orleans, Louisiana, 70127
Research Site 17
New Port Richey, Florida, 34653
Research Site 49
New York, New York, 10033
Research Site 117
North Little Rock, Arkansas, 72117
Research Site 02
Oak Lawn, Illinois, 60453
Research Site 90
Ocoee, Florida, 34761
Research Site 05
Palmetto Bay, Florida, 33157
Research Site 32
Pearland, Texas, 77584
Research Site 62
Phoenix, Arizona, 85018
Research Site 30
Red Oak, Texas, 75154
Research Site 64
Reno, Nevada, 89511
Research Site 40
Rochester, New York, 14609
Research Site 22
San Antonio, Texas, 78209
Research Site 26
San Antonio, Texas, 78229
Research Site 21
San Antonio, Texas, 78249
Research Site 65
Sandy City, Utah, 84092
Research Site 59
Sandy Springs, Georgia, 30328
Research Site 13
Santa Ana, California, 92704
Research Site 41
Santa Maria, California, 93458
Research Site 16
South Ogden, Utah, 84405
Research Site 11
Sunrise, Florida, 33351
Research Site 27
Tucson, Arizona, 85712
Research Site 46
Viera, Florida, 32940
Research Site 110
Westlake, Ohio, 44145
About this study
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).
- Conditions
- Non-erosive Reflux Disease, Erosive Esophagitis
- Being tested
- BLI5100
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI5100Drug
Patients will take BLI5100 once daily, orally, for up to 29 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BLI5100 Low Dose | Experimental | Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks. Receives: Drug: BLI5100 |
| BLI5100 High Dose | Experimental | Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks. Receives: Drug: BLI5100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-emergent adverse events
Measured: 31 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start5 Apr 2023
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890001
- Sponsor's protocol ID
- BLI5100-303
- Status last verified
- Sep 2025
- First submitted
- 5 May 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05890001
- Acronym / sponsor ID
- BLI5100-303
- Conditions
- Non-erosive Reflux Disease, Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLI5100 Low Dose | Experimental | Drug: BLI5100Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks. |
| BLI5100 High Dose | Experimental | Drug: BLI5100Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
- Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies;
- Requirement of persistent (>3 times per week for >30 days) use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study;
- o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLI5100Patients will take BLI5100 once daily, orally, for up to 29 weeks. | Drug | BLI5100 High Dose, BLI5100 Low Dose |
Primary outcome
Frequency of treatment-emergent adverse events
Time frame: 31 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BLI5100 in people with Non-erosive Reflux Disease and Erosive Esophagitis, run by Braintree Laboratories at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events (time frame: 31 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.