Non-erosive Reflux DiseasePhase 3NCT05587322
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
A Phase 3 study testing BLI5100 in people with Non-erosive Reflux Disease, run by Braintree Laboratories at 112 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- BLI5100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 788 participants
- Where
- 112 sitesUnited States
- Study dates
- 6 Sep 2022to 23 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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:
Show all 37Show fewer
- 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 .
Trial locations and contacts
112 sites in 1 country.
112 sites in 1 country
United States112 sites
Research Site 51
Arcadia, California, 91006
Research Site 112
Aurora, Colorado, 80012
Research Site 126
Bakersfield, California, 93309
Research Site 115
Beaumont, Texas, 77701
Research Site 66
Bell Gardens, California, 90201
Research Site 100
Bellaire, Texas, 77401
Research Site 74
Boca Raton, Florida, 33434
Research Site 35
Brooklyn, New York, 11235
Research Site 19
Canoga Park, California, 91304
Research Site 77
Chesapeake, Virginia, 23320
Research Site 93
Chesterfield, Michigan, 48047
Research Site 111
Chesterfield, Missouri, 63005
Research Site 94
Chula Vista, California, 91910
Research Site 137
Columbia, Missouri, 65201
Research Site 20
Columbus, Ohio, 43213
Research Site 88
Columbus, Ohio, 43215
Research Site 108
Cooper City, Florida, 33024
Research Site 125
Covington, Louisiana, 70433
Research Site 98
Dallas, Texas, 75230
Research Site 91
Doral, Florida, 33172
Research Site 102
Downers Grove, Illinois, 60515
Research Site 129
Englewood, New Jersey, 07631
Research Site 75
Fayetteville, North Carolina, 28304
Research Site 99
Forney, Texas, 75126
Research Site 130
Freehold, New Jersey, 07728
Research Site 07
Great Neck, New York, 11023
Research Site 01
Gurnee, Illinois, 60031
Research Site 28
Hartsdale, New York, 10530
Research Site 128
Hermitage, Tennessee, 37076
Research Site 03
Hialeah, Florida, 33013
Research Site 78
Homestead, Florida, 33030
Research Site 45
Houma, Louisiana, 70363
Research Site 10
Huntington Park, California, 90255
Research Site 24
Huntsville, Alabama, 35801
Research Site 101
Idaho Falls, Idaho, 83404
Research Site 131
Jackson, New Jersey, 08527
Research Site 68
Katy, Texas, 77494
Research Site 114
Kingsport, Tennessee, 37663
Research Site 55
La Mesa, California, 91942
Research Site 09
Lake City, Florida, 32055
Research Site 06
Las Vegas, Nevada, 89106
Research Site 73
Las Vegas, Nevada, 89109
Research Site 127
Las Vegas, Nevada, 89128
Research Site 29
Lewisville, Texas, 75057
Research Site 87
Little Rock, Arkansas, 72211
Research Site 89
Littleton, Colorado, 80120
Research Site 120
Long Beach, California, 90808
Research Site 72
Los Angeles, California, 90017
Research Site 54
Los Angeles, California, 90057
Research Site 23
Maitland, Florida, 32751
Research Site 04
Marietta, Georgia, 30060
Research Site 12
Marrero, Louisiana, 70072
Research Site 109
Mentor, Ohio, 44060
Research Site 124
Metairie, Louisiana, 70006
Research Site 48
Metairie, Louisiana, 70006
Research Site 38
Miami, Florida, 33134
Research Site 43
Miami, Florida, 33136
Research Site 81
Miami, Florida, 33142
Research Site 67
Miami, Florida, 33155
Research Site 92
Miami, Florida, 33173
Research Site 31
Miami, Florida, 33185
Research Site 71
Miami, Florida, 33186
Research Site 42
Miami Lakes, Florida, 33014
Research Site 18
Mission Viejo, California, 92691
Research Site 97
Morgantown, West Virginia, 26505
Research Site 69
Mount Airy, North Carolina, 27030
Research Site 60
Nashville, Tennessee, 37203
Research Site 103
Nashville, Tennessee, 37211
Research Site 34
New Orleans, Louisiana, 70127
Research Site 17
New Port Richey, Florida, 34653
Research Site 58
New York, New York, 10021
Research Site 49
New York, New York, 10033
Research Site 61
North Charleston, South Carolina, 29405
Research Site 117
North Little Rock, Arkansas, 72117
Research Site 113
Northbrook, Illinois, 60062
Research Site 02
Oak Lawn, Illinois, 60453
Research Site 90
Ocoee, Florida, 34761
Research Site 105
Ogden, Utah, 84403
Research Site 107
Orlando, Florida, 32807
Research Site 05
Palmetto Bay, Florida, 33157
Research Site 32
Pearland, Texas, 77584
Research Site 132
Peoria, Arizona, 85381
Research Site 62
Phoenix, Arizona, 85018
Research Site 30
Red Oak, Texas, 75154
Research Site 64
Reno, Nevada, 89511
Research Site 136
Richmond, Virginia, 23236
Research Site 40
Rochester, New York, 14609
Research Site 116
Salisbury, North Carolina, 28144
Research Site 57
Salt Lake City, Utah, 84107
Research Site 106
Salt Lake City, Utah, 84124
Research Site 22
San Antonio, Texas, 78209
Research Site 26
San Antonio, Texas, 78229
Research Site 21
San Antonio, Texas, 78249
Research Site 14
San Diego, California, 92120
Research Site 65
Sandy City, Utah, 84092
Research Site 59
Sandy Springs, Georgia, 30328
Research Site 85
Santa Ana, California, 92703
Research Site 13
Santa Ana, California, 92704
Research Site 41
Santa Maria, California, 93458
Research Site 50
Shelbyville, Tennessee, 37160
Research Site 135
South Bend, Indiana, 46635
Research Site 16
South Ogden, Utah, 84405
Research Site 118
Springboro, Ohio, 45066
Research Site 95
St. Petersburg, Florida, 33709
Research Site 11
Sunrise, Florida, 33351
Research Site 80
Tomball, Texas, 77375
Research Site 27
Tucson, Arizona, 85712
Research Site 46
Viera, Florida, 32940
Research Site 134
Waco, Texas, 76710
Research Site 25
West Monroe, Louisiana, 71291
Research Site 110
Westlake, Ohio, 44145
Research Site 121
Wichita Falls, Texas, 76301
About this study
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
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.
- Conditions
- Non-erosive Reflux Disease
- Being tested
- BLI5100, Placebo
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI5100Drug
Orally via tablet
PlaceboDrug
Orally via tablet
| Study group | Role | What they receive |
|---|---|---|
| BLI5100 Low Dose | Experimental | 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. Receives: Drug: BLI5100 |
| BLI5100 High Dose | Experimental | 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. Receives: Drug: BLI5100 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of 24-Hour Heartburn Free Days Through Week 4 of Treatment Phase
Participants were assigned an electronic heartburn diary (eDiary) to complete twice daily, in the morning (AM) and evening (PM). A heartburn-free day was defined as a day with no heartburn reported in the morning (AM) or evening (PM) diary entries.
Measured: 4 Weeks
Secondary outcomes (1)
Percentage of Days Without Nighttime Heartburn Through Week 4 of Treatment Phase
A heartburn-free day was defined as a day with no heartburn reported in the evening (PM) diary entry.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start6 Sep 2022
- Primary completion13 Oct 2023
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leah Hollins, Study director, Braintree Laboratories / Sebela Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587322
- Sponsor's protocol ID
- BLI5100-302
- Status last verified
- Jul 2024
- First submitted
- 17 Oct 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05587322
- Acronym / sponsor ID
- BLI5100-302
- Conditions
- Non-erosive Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLI5100 Low Dose | Experimental | Drug: BLI5100During 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 | Experimental | Drug: BLI5100During 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 comparator | Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (37 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLI5100Orally via tablet | Drug | BLI5100 High Dose, BLI5100 Low Dose |
| PlaceboOrally via tablet | Drug | Placebo |
Primary outcome
Percentage of 24-Hour Heartburn Free Days Through Week 4 of Treatment Phase
Time frame: 4 Weeks
Participants were assigned an electronic heartburn diary (eDiary) to complete twice daily, in the morning (AM) and evening (PM). A heartburn-free day was defined as a day with no heartburn reported in the morning (AM) or evening (PM) diary entries.
1 secondary outcome
Percentage of Days Without Nighttime Heartburn Through Week 4 of Treatment Phase
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Non-erosive Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Not yet recruiting
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
Nocturnal Symptoms of GERD, Sleep Disorders in GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Hollins study director
Braintree Laboratories / Sebela Pharmaceuticals
112 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BLI5100 in people with Non-erosive Reflux Disease, run by Braintree Laboratories at 112 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of 24-Hour Heartburn Free Days Through Week 4 of Treatment Phase (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.