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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05890001
Other study ID # BLI5100-303
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date April 5, 2023
Est. completion date September 30, 2024

Study information

Verified date January 2024
Source Braintree Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 400
Est. completion date September 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Have completed the BLI5100-301 or BLI5100-302 study with no serious AE (SAE) related to study drug and no major Protocol Deviations; 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: 1. 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. 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.

Study Design


Intervention

Drug:
BLI5100
Patients will take BLI5100 once daily, orally, for up to 29 weeks.

Locations

Country Name City State
United States Research Site 100 Bellaire Texas
United States Research Site 35 Brooklyn New York
United States Research Site 111 Chesterfield Missouri
United States Research Site 94 Chula Vista California
United States Research Site 20 Columbus Ohio
United States Research Site 88 Columbus Ohio
United States Research Site 108 Cooper City Florida
United States Research Site 98 Dallas Texas
United States Research Site 91 Doral Florida
United States Research Site 75 Fayetteville North Carolina
United States Research Site 99 Forney Texas
United States Research Site 07 Great Neck New York
United States Research Site 01 Gurnee Illinois
United States Research Site 28 Hartsdale New York
United States Research Site 78 Homestead Florida
United States Research Site 45 Houma Louisiana
United States Research Site 10 Huntington Park California
United States Research Site 24 Huntsville Alabama
United States Research Site 55 La Mesa California
United States Research Site 06 Las Vegas Nevada
United States Research Site 29 Lewisville Texas
United States Research Site 87 Little Rock Arkansas
United States Research Site 54 Los Angeles California
United States Research Site 72 Los Angeles California
United States Research Site 23 Maitland Florida
United States Research Site 12 Marrero Louisiana
United States Research Site 109 Mentor Ohio
United States Research Site 48 Metairie Louisiana
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 71 Miami Florida
United States Research Site 92 Miami Florida
United States Research Site 42 Miami Lakes Florida
United States Research Site 103 Nashville Tennessee
United States Research Site 60 Nashville Tennessee
United States Research Site 34 New Orleans Louisiana
United States Research Site 17 New Port Richey Florida
United States Research Site 49 New York New York
United States Research Site 117 North Little Rock Arkansas
United States Research Site 02 Oak Lawn Illinois
United States Research Site 90 Ocoee Florida
United States Research Site 05 Palmetto Bay Florida
United States Research Site 32 Pearland Texas
United States Research Site 62 Phoenix Arizona
United States Research Site 30 Red Oak Texas
United States Research Site 64 Reno Nevada
United States Research Site 40 Rochester New York
United States Research Site 21 San Antonio Texas
United States Research Site 22 San Antonio Texas
United States Research Site 26 San Antonio Texas
United States Research Site 65 Sandy Utah
United States Research Site 59 Sandy Springs Georgia
United States Research Site 13 Santa Ana California
United States Research Site 41 Santa Maria California
United States Research Site 16 South Ogden Utah
United States Research Site 11 Sunrise Florida
United States Research Site 27 Tucson Arizona
United States Research Site 46 Viera Florida
United States Research Site 110 Westlake Ohio

Sponsors (1)

Lead Sponsor Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of treatment-emergent adverse events 31 Weeks
See also
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Completed NCT02679508 - Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety Phase 4
Recruiting NCT06391177 - A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily Phase 1
Completed NCT05050188 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008 Phase 1
Completed NCT01874535 - Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy Phase 4
Completed NCT00206180 - NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Phase 4
Completed NCT01642615 - Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents Phase 2
Completed NCT01630746 - A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis Phase 3