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A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

Primary Purpose

Non-erosive Reflux Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BLI5100
Placebo
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-erosive Reflux Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged ≥18 years at the time of signing informed consent;
  2. Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;
  3. Have documented history of symptomatic GERD;
  4. Have no mucosal break(s) on the upper GI endoscopy performed during Screening;
  5. Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;
  6. Able to understand and comply with the protocol requirements;
  7. Willing and able to provide written informed consent at Screening;
  8. Is a female of non-childbearing potential, ie, is either surgically sterile (ie, had a hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy ≥6 months before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for ≥12 months, and, for females <55 years of age, with follicle-stimulating hormone in the post-menopausal range at Screening, based on the central laboratory's ranges; or If a female of childbearing potential, agrees to use an acceptable form of birth control from the Screening Visit until 30 days after the last dose of study drug.
  9. 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.
  10. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.

Exclusion Criteria:

  1. Unable to undergo an upper GI endoscopy;
  2. 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.

  3. 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;
  4. 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;
  5. 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.
  6. 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;
  7. History of acid-suppressive, esophageal, or gastric surgery;

    o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.

  8. 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.

  9. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
  10. 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;

    o Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening.

  11. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder;
  12. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
  13. Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
  14. Use of 2 or more commercial doses of reflux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, prokinetics, and antacids) within 1 week prior to the upper GI endoscopy at Screening;
  15. Requirement of persistent 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.

  16. 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;
  17. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;
  18. 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; or
    • Serum magnesium <lower limit of normal.
  19. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);
  20. Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;
  21. Involvement in another clinical study within 4 weeks of initiation of study drug; or
  22. 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 .

Sites / Locations

  • Research Site 24
  • Research Site 132
  • Research Site 62
  • Research Site 27
  • Research Site 87
  • Research Site 117
  • Research Site 51
  • Research Site 126
  • Research Site 66
  • Research Site 19
  • Research Site 94
  • Research Site 10
  • Research Site 55
  • Research Site 120
  • Research Site 72
  • Research Site 54
  • Research Site 14
  • Research Site 85
  • Research Site 13
  • Research Site 41
  • Research Site 112
  • Research Site 89
  • Research Site 74
  • Research Site 108
  • Research Site 91
  • Research Site 03
  • Research Site 78
  • Research Site 09
  • Research Site 23
  • Research Site 42
  • Research Site 38
  • Research Site 43
  • Research Site 81
  • Research Site 67
  • Research Site 92
  • Research Site 31
  • Research Site 71
  • Research Site 17
  • Research Site 90
  • Research Site 107
  • Research Site 05
  • Research Site 95
  • Research Site 11
  • Research Site 46
  • Research Site 04
  • Research Site 59
  • Research Site 101
  • Research Site 102
  • Research Site 01
  • Research Site 113
  • Research Site 02
  • Research Site 135
  • Research Site 125
  • Research Site 45
  • Research Site 12
  • Research Site 124
  • Research Site 48
  • Research Site 34
  • Research Site 25
  • Research Site 93
  • Research Site 111
  • Research Site 137
  • Research Site 06
  • Research Site 73
  • Research Site 127
  • Research Site 64
  • Research Site 129
  • Research Site 130
  • Research Site 131
  • Research Site 35
  • Research Site 07
  • Research Site 28
  • Research Site 58
  • Research Site 49
  • Research Site 40
  • Research Site 75
  • Research Site 69
  • Research Site 116
  • Research Site 20
  • Research Site 88
  • Research Site 109
  • Research Site 118
  • Research Site 110
  • Research Site 61
  • Research Site 128
  • Research Site 114
  • Research Site 60
  • Research Site 103
  • Research Site 50
  • Research Site 115
  • Research Site 100
  • Research Site 98
  • Research Site 99
  • Research Site 68
  • Research Site 29
  • Research Site 32
  • Research Site 30
  • Research Site 22
  • Research Site 26
  • Research Site 21
  • Research Site 80
  • Research Site 134
  • Research Site 121
  • Research Site 105
  • Research Site 57
  • Research Site 106
  • Research Site 65
  • Research Site 16
  • Research Site 77
  • Research Site 136
  • Research Site 97

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BLI5100 Low Dose

BLI5100 High Dose

Placebo

Arm Description

During 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.

During 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.

During 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.

Outcomes

Primary Outcome Measures

Percentage of 24-hour heartburn-free days

Secondary Outcome Measures

Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)

Full Information

First Posted
October 17, 2022
Last Updated
October 23, 2023
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT05587322
Brief Title
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
January 26, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLI5100 Low Dose
Arm Type
Experimental
Arm Description
During 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.
Arm Title
BLI5100 High Dose
Arm Type
Experimental
Arm Description
During 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During 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.
Intervention Type
Drug
Intervention Name(s)
BLI5100
Intervention Description
Orally via tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally via tablet
Primary Outcome Measure Information:
Title
Percentage of 24-hour heartburn-free days
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening. 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. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder; o Note: A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is not exclusionary, as long as the patient is asymptomatic and well-controlled on stable treatment (ie, stable dose for >6 months prior to Screening), including non-medical therapy. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening; Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening; Use of 2 or more commercial doses of reflux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, prokinetics, and antacids) within 1 week prior to the upper GI endoscopy at Screening; 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. 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; Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening; Positive test result for H. pylori at Screening or diagnosis and treatment of H. pylori within 4 to 6 weeks prior to Randomization; o Note: Patients who test positive for H. pylori at Screening will be offered treatment according to local standard of care and may be re-screened for eligibility following completion of treatment. 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; or Serum magnesium <lower limit of normal. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly); Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome; Involvement in another clinical study within 4 weeks of initiation of study drug; or 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Hollins
Organizational Affiliation
Braintree Laboratories / Sebela Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site 24
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site 132
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Site 62
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site 27
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research Site 87
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Research Site 117
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Research Site 51
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
Research Site 126
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Research Site 66
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Research Site 19
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Research Site 94
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Site 10
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Research Site 55
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Research Site 120
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Research Site 72
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Research Site 54
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Research Site 14
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Research Site 85
City
Santa Ana
State/Province
California
ZIP/Postal Code
92703
Country
United States
Facility Name
Research Site 13
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Research Site 41
City
Santa Maria
State/Province
California
ZIP/Postal Code
93458
Country
United States
Facility Name
Research Site 112
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Research Site 89
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Research Site 74
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Research Site 108
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Research Site 91
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Research Site 03
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Research Site 78
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Research Site 09
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Research Site 23
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Research Site 42
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Research Site 38
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site 43
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site 81
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Research Site 67
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Site 92
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site 31
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Research Site 71
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Research Site 17
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Research Site 90
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Research Site 107
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Research Site 05
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Research Site 95
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Research Site 11
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Research Site 46
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Facility Name
Research Site 04
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Research Site 59
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Research Site 101
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Research Site 102
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Research Site 01
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Research Site 113
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Research Site 02
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Research Site 135
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Research Site 125
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Research Site 45
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Facility Name
Research Site 12
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Research Site 124
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Site 48
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Site 34
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Facility Name
Research Site 25
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Research Site 93
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Research Site 111
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Research Site 137
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Research Site 06
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site 73
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Research Site 127
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Research Site 64
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Research Site 129
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Research Site 130
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Research Site 131
City
Jackson
State/Province
New Jersey
ZIP/Postal Code
08527
Country
United States
Facility Name
Research Site 35
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Research Site 07
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Site 28
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Research Site 58
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site 49
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
Research Site 40
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Research Site 75
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Research Site 69
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Research Site 116
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Research Site 20
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Site 88
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site 109
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Research Site 118
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Research Site 110
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Research Site 61
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Research Site 128
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Research Site 114
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37663
Country
United States
Facility Name
Research Site 60
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site 103
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Research Site 50
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Research Site 115
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Research Site 100
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Research Site 98
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site 99
City
Forney
State/Province
Texas
ZIP/Postal Code
75126
Country
United States
Facility Name
Research Site 68
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Research Site 29
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Research Site 32
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Research Site 30
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
Research Site 22
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Research Site 26
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site 21
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Research Site 80
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Research Site 134
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Research Site 121
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Research Site 105
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Research Site 57
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site 106
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Site 65
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
Research Site 16
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Research Site 77
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Research Site 136
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Facility Name
Research Site 97
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

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