A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
NCT ID: NCT05890001
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2023-04-05
2024-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BLI5100 Low Dose
Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.
BLI5100
Patients will take BLI5100 once daily, orally, for up to 29 weeks.
BLI5100 High Dose
Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.
BLI5100
Patients will take BLI5100 once daily, orally, for up to 29 weeks.
Interventions
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BLI5100
Patients will take BLI5100 once daily, orally, for up to 29 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Able to understand and comply with the protocol requirements;
3. Willing and able to provide written informed consent at Screening;
4. 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;
5. 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;
6. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug;
7. Have documented healed EE (BLI5100-301 study patients only).
Exclusion Criteria
* 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.
2. 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;
3. 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;
4. 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.
5. 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;
6. 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.
7. Abnormal ECG of clinical significance;
8. Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) within 4 weeks of initiation of study drug;
9. 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.
18 Years
85 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Locations
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Research Site 24
Huntsville, Alabama, United States
Research Site 62
Phoenix, Arizona, United States
Research Site 27
Tucson, Arizona, United States
Research Site 87
Little Rock, Arkansas, United States
Research Site 117
North Little Rock, Arkansas, United States
Research Site 94
Chula Vista, California, United States
Research Site 10
Huntington Park, California, United States
Research Site 55
La Mesa, California, United States
Research Site 72
Los Angeles, California, United States
Research Site 54
Los Angeles, California, United States
Research Site 13
Santa Ana, California, United States
Research Site 41
Santa Maria, California, United States
Research Site 108
Cooper City, Florida, United States
Research Site 91
Doral, Florida, United States
Research Site 78
Homestead, Florida, United States
Research Site 23
Maitland, Florida, United States
Research Site 38
Miami, Florida, United States
Research Site 43
Miami, Florida, United States
Research Site 67
Miami, Florida, United States
Research Site 92
Miami, Florida, United States
Research Site 71
Miami, Florida, United States
Research Site 42
Miami Lakes, Florida, United States
Research Site 17
New Port Richey, Florida, United States
Research Site 90
Ocoee, Florida, United States
Research Site 05
Palmetto Bay, Florida, United States
Research Site 11
Sunrise, Florida, United States
Research Site 46
Viera, Florida, United States
Research Site 59
Sandy Springs, Georgia, United States
Research Site 01
Gurnee, Illinois, United States
Research Site 02
Oak Lawn, Illinois, United States
Research Site 45
Houma, Louisiana, United States
Research Site 12
Marrero, Louisiana, United States
Research Site 48
Metairie, Louisiana, United States
Research Site 34
New Orleans, Louisiana, United States
Research Site 111
Chesterfield, Missouri, United States
Research Site 06
Las Vegas, Nevada, United States
Research Site 64
Reno, Nevada, United States
Research Site 35
Brooklyn, New York, United States
Research Site 07
Great Neck, New York, United States
Research Site 28
Hartsdale, New York, United States
Research Site 49
New York, New York, United States
Research Site 40
Rochester, New York, United States
Research Site 75
Fayetteville, North Carolina, United States
Research Site 20
Columbus, Ohio, United States
Research Site 88
Columbus, Ohio, United States
Research Site 109
Mentor, Ohio, United States
Research Site 110
Westlake, Ohio, United States
Research Site 60
Nashville, Tennessee, United States
Research Site 103
Nashville, Tennessee, United States
Research Site 100
Bellaire, Texas, United States
Research Site 98
Dallas, Texas, United States
Research Site 99
Forney, Texas, United States
Research Site 29
Lewisville, Texas, United States
Research Site 32
Pearland, Texas, United States
Research Site 30
Red Oak, Texas, United States
Research Site 22
San Antonio, Texas, United States
Research Site 26
San Antonio, Texas, United States
Research Site 21
San Antonio, Texas, United States
Research Site 65
Sandy City, Utah, United States
Research Site 16
South Ogden, Utah, United States
Countries
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Other Identifiers
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BLI5100-303
Identifier Type: -
Identifier Source: org_study_id
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