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

Primary Purpose

Non-erosive Reflux Disease, Erosive Esophagitis

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BLI5100
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: 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 from the Screening Visit until 30 days 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; Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening. 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. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder; 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 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 30 days 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. 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.

Sites / Locations

  • Research Site 24
  • Research Site 62
  • Research Site 94
  • Research Site 10
  • Research Site 72
  • Research Site 13
  • Research Site 41
  • Research Site 91
  • Research Site 23
  • Research Site 42
  • Research Site 38
  • Research Site 43
  • Research Site 17
  • Research Site 90
  • Research Site 11
  • Research Site 46
  • Research Site 59
  • Research Site 01
  • Research Site 02
  • Research Site 45
  • Research Site 12
  • Research Site 48
  • Research Site 06
  • Research Site 64
  • Research Site 35
  • Research Site 07
  • Research Site 28
  • Research Site 40
  • Research Site 20
  • Research Site 60
  • Research Site 103
  • Research Site 100
  • Research Site 98
  • Research Site 29
  • Research Site 32
  • Research Site 22
  • Research Site 26
  • Research Site 65
  • Research Site 16

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BLI5100 Low Dose

BLI5100 High Dose

Arm Description

Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.

Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.

Outcomes

Primary Outcome Measures

Frequency of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
July 26, 2023
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT05890001
Brief Title
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
Official Title
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 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 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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BLI5100 Low Dose
Arm Type
Experimental
Arm Description
Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.
Arm Title
BLI5100 High Dose
Arm Type
Experimental
Arm Description
Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.
Intervention Type
Drug
Intervention Name(s)
BLI5100
Intervention Description
Patients will take BLI5100 once daily, orally, for up to 29 weeks.
Primary Outcome Measure Information:
Title
Frequency of treatment-emergent adverse events
Time Frame
31 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: 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 from the Screening Visit until 30 days 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; Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening. 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. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder; 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 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 30 days 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. 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.
Facility Information:
Facility Name
Research Site 24
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site 62
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
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 72
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
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 91
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
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 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 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 59
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Research Site 01
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
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 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 48
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
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 64
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
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 40
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Research Site 20
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
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 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 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 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 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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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