A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
1 other identifier
interventional
800
1 country
112
Brief Summary
The objective of the Treatment Phase of the study is to evaluate the safety and efficacy of 4 weeks of once daily oral administration of BLI5100 low dose, BLI5100 high dose, or placebo in patients with NERD. The objective of the Extension Phase of the study is to evaluate the safety of extended exposure to once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2022
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2024
CompletedJuly 24, 2024
July 1, 2024
1.1 years
October 17, 2022
July 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of 24-hour heartburn-free days
4 Weeks
Secondary Outcomes (1)
Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)
4 Weeks
Study Arms (3)
BLI5100 Low Dose
EXPERIMENTALDuring 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.
BLI5100 High Dose
EXPERIMENTALDuring 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.
Placebo
PLACEBO COMPARATORDuring 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.
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥18 years at the time of signing informed consent;
- Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;
- Have documented history of symptomatic GERD;
- Have no mucosal break(s) on the upper GI endoscopy performed during Screening;
- Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;
- Able to understand and comply with the protocol requirements;
- Willing and able to provide written informed consent at Screening;
- A female of reproductive potential defined as a non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure; 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.
You may not qualify if:
- Unable to undergo an upper GI endoscopy;
- Presence of esophageal stricture, gastroesophageal varix (including post sclerotherapy or ligation), untreated Barrett's esophagus, gastric bleeding, infection, tumor, or gastric or duodenal ulcer on the upper GI endoscopy;
- o Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
- Diagnosed with erosive gastroesophageal reflux disease, acute upper GI bleeding, gastric ulcer or duodenal ulcer, or acute gastritis within 2 months prior to the upper GI endoscopy;
- Alarm symptoms such as odynophagia, severe dysphagia, upper GI bleeding, weight loss, anemia, or hematochezia within 4 weeks prior to Screening, unless the presumed malignancy is ruled out;
- History or suspicion of functional upper gastrointestinal disorders, such as:
- Functional heartburn, as described in the Rome IV criteria, or
- Functional dyspepsia, as described in the Rome IV criteria.
- History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease, or documented history of delayed gastric emptying;
- History of acid-suppressive, esophageal, or gastric surgery;
- o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.
- History of malignancy within the past 5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin);
- o Note: This is not applicable to patients who had complete response or pathological complete response and whose tumor had not recurred for at least 5 years from the date of last treatment, or patients whose tumor had been removed by endoscopic resection without any findings indicating recurrence of the tumor within 3 years.
- History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
- History of alcoholism, chronic opiate use, or substance addiction in the 12 months before Screening or a positive urine drug screen for opiates or substances of abuse;
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Research Site 24
Huntsville, Alabama, 35801, United States
Research Site 132
Peoria, Arizona, 85381, United States
Research Site 62
Phoenix, Arizona, 85018, United States
Research Site 27
Tucson, Arizona, 85712, United States
Research Site 87
Little Rock, Arkansas, 72211, United States
Research Site 117
North Little Rock, Arkansas, 72117, United States
Research Site 51
Arcadia, California, 91006, United States
Research Site 126
Bakersfield, California, 93309, United States
Research Site 66
Bell Gardens, California, 90201, United States
Research Site 19
Canoga Park, California, 91304, United States
Research Site 94
Chula Vista, California, 91910, United States
Research Site 10
Huntington Park, California, 90255, United States
Research Site 55
La Mesa, California, 91942, United States
Research Site 120
Long Beach, California, 90808, United States
Research Site 72
Los Angeles, California, 90017, United States
Research Site 54
Los Angeles, California, 90057, United States
Research Site 18
Mission Viejo, California, 92691, United States
Research Site 14
San Diego, California, 92120, United States
Research Site 85
Santa Ana, California, 92703, United States
Research Site 13
Santa Ana, California, 92704, United States
Research Site 41
Santa Maria, California, 93458, United States
Research Site 112
Aurora, Colorado, 80012, United States
Research Site 89
Littleton, Colorado, 80120, United States
Research Site 74
Boca Raton, Florida, 33434, United States
Research Site 108
Cooper City, Florida, 33024, United States
Research Site 91
Doral, Florida, 33172, United States
Research Site 03
Hialeah, Florida, 33013, United States
Research Site 78
Homestead, Florida, 33030, United States
Research Site 09
Lake City, Florida, 32055, United States
Research Site 23
Maitland, Florida, 32751, United States
Research Site 38
Miami, Florida, 33134, United States
Research Site 43
Miami, Florida, 33136, United States
Research Site 81
Miami, Florida, 33142, United States
Research Site 67
Miami, Florida, 33155, United States
Research Site 92
Miami, Florida, 33173, United States
Research Site 31
Miami, Florida, 33185, United States
Research Site 71
Miami, Florida, 33186, United States
Research Site 42
Miami Lakes, Florida, 33014, United States
Research Site 17
New Port Richey, Florida, 34653, United States
Research Site 90
Ocoee, Florida, 34761, United States
Research Site 107
Orlando, Florida, 32807, United States
Research Site 05
Palmetto Bay, Florida, 33157, United States
Research Site 95
St. Petersburg, Florida, 33709, United States
Research Site 11
Sunrise, Florida, 33351, United States
Research Site 46
Viera, Florida, 32940, United States
Research Site 04
Marietta, Georgia, 30060, United States
Research Site 59
Sandy Springs, Georgia, 30328, United States
Research Site 101
Idaho Falls, Idaho, 83404, United States
Research Site 102
Downers Grove, Illinois, 60515, United States
Research Site 01
Gurnee, Illinois, 60031, United States
Research Site 113
Northbrook, Illinois, 60062, United States
Research Site 02
Oak Lawn, Illinois, 60453, United States
Research Site 135
South Bend, Indiana, 46635, United States
Research Site 125
Covington, Louisiana, 70433, United States
Research Site 45
Houma, Louisiana, 70363, United States
Research Site 12
Marrero, Louisiana, 70072, United States
Research Site 124
Metairie, Louisiana, 70006, United States
Research Site 48
Metairie, Louisiana, 70006, United States
Research Site 34
New Orleans, Louisiana, 70127, United States
Research Site 25
West Monroe, Louisiana, 71291, United States
Research Site 93
Chesterfield, Michigan, 48047, United States
Research Site 111
Chesterfield, Missouri, 63005, United States
Research Site 137
Columbia, Missouri, 65201, United States
Research Site 06
Las Vegas, Nevada, 89106, United States
Research Site 73
Las Vegas, Nevada, 89109, United States
Research Site 127
Las Vegas, Nevada, 89128, United States
Research Site 64
Reno, Nevada, 89511, United States
Research Site 129
Englewood, New Jersey, 07631, United States
Research Site 130
Freehold, New Jersey, 07728, United States
Research Site 131
Jackson, New Jersey, 08527, United States
Research Site 35
Brooklyn, New York, 11235, United States
Research Site 07
Great Neck, New York, 11023, United States
Research Site 28
Hartsdale, New York, 10530, United States
Research Site 58
New York, New York, 10021, United States
Research Site 49
New York, New York, 10033, United States
Research Site 40
Rochester, New York, 14609, United States
Research Site 75
Fayetteville, North Carolina, 28304, United States
Research Site 69
Mount Airy, North Carolina, 27030, United States
Research Site 116
Salisbury, North Carolina, 28144, United States
Research Site 20
Columbus, Ohio, 43213, United States
Research Site 88
Columbus, Ohio, 43215, United States
Research Site 109
Mentor, Ohio, 44060, United States
Research Site 118
Springboro, Ohio, 45066, United States
Research Site 110
Westlake, Ohio, 44145, United States
Research Site 61
North Charleston, South Carolina, 29405, United States
Research Site 128
Hermitage, Tennessee, 37076, United States
Research Site 114
Kingsport, Tennessee, 37663, United States
Research Site 60
Nashville, Tennessee, 37203, United States
Research Site 103
Nashville, Tennessee, 37211, United States
Research Site 50
Shelbyville, Tennessee, 37160, United States
Research Site 115
Beaumont, Texas, 77701, United States
Research Site 100
Bellaire, Texas, 77401, United States
Research Site 98
Dallas, Texas, 75230, United States
Research Site 99
Forney, Texas, 75126, United States
Research Site 68
Katy, Texas, 77494, United States
Research Site 29
Lewisville, Texas, 75057, United States
Research Site 32
Pearland, Texas, 77584, United States
Research Site 30
Red Oak, Texas, 75154, United States
Research Site 22
San Antonio, Texas, 78209, United States
Research Site 26
San Antonio, Texas, 78229, United States
Research Site 21
San Antonio, Texas, 78249, United States
Research Site 80
Tomball, Texas, 77375, United States
Research Site 134
Waco, Texas, 76710, United States
Research Site 121
Wichita Falls, Texas, 76301, United States
Research Site 105
Ogden, Utah, 84403, United States
Research Site 57
Salt Lake City, Utah, 84107, United States
Research Site 106
Salt Lake City, Utah, 84124, United States
Research Site 65
Sandy City, Utah, 84092, United States
Research Site 16
South Ogden, Utah, 84405, United States
Research Site 77
Chesapeake, Virginia, 23320, United States
Research Site 136
Richmond, Virginia, 23236, United States
Research Site 97
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leah Hollins
Braintree Laboratories / Sebela Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
September 6, 2022
Primary Completion
October 13, 2023
Study Completion
April 23, 2024
Last Updated
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share