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NCT05890001
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
Phase 3 trial testing BLI5100 in Non-erosive Reflux Disease in 400 participants. Completed in 8 October 2024.
8 October 2024
Quick facts
| Lead sponsor | Braintree Laboratories |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 5 April 2023 |
| Primary completion | 8 October 2024 |
| Estimated completion | 8 October 2024 |
| Sites | 60 locations across United States |
Drugs / interventions tested
- BLI5100 — full drug profile →
Conditions studied
- Non-erosive Reflux Disease — all drugs for Non-erosive Reflux Disease →
- Erosive Esophagitis — all drugs for Erosive Esophagitis →
Sponsor
Braintree Laboratories — full company profile →
Who can join
Adults 18 to 85, any sex, with Non-erosive Reflux Disease or Erosive Esophagitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05890001
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BLI5100
Trials testing the same drug.
- NCT05587309 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis · Phase 3 · completed
- NCT05587322 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease · Phase 3 · completed
Other recruiting trials for Non-erosive Reflux Disease
Currently open trials in the same condition.
- NCT04255693 — Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence · NA · recruiting
Other Braintree Laboratories trials
Trials by the same sponsor.
- NCT05587309 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis · Phase 3 · completed
- NCT05587322 — A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease · Phase 3 · completed
- NCT04446312 — Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy · Phase 3 · completed
- NCT04446299 — Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy · Phase 3 · completed
- NCT04214301 — An Open-Label Preference Evaluation of BLI800 · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05890001 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Braintree Laboratories
- Last refreshed: 26 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05890001.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing