Erosive Esophagitis Clinical Trial
Official title:
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
Verified date | January 2024 |
Source | Braintree Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Braintree Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of treatment-emergent adverse events | 31 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01452776 -
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Recruiting |
NCT05587309 -
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT04124926 -
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01459367 -
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
Completed |
NCT01499368 -
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
|
Phase 3 | |
Not yet recruiting |
NCT04613895 -
Treatment Effect According to Timing of Administration of DWP14012 40 mg
|
N/A | |
Recruiting |
NCT02615184 -
A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children
|
Phase 2 | |
Completed |
NCT02456935 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02028663 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 2 | |
Completed |
NCT03006874 -
Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT02388724 -
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT01865825 -
Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
|
N/A | |
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 |