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NCT05587309 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

A Phase 3 study, sponsored by Braintree Laboratories.

Completed
Registry status
Phase 3
Development phase
1,250
Enrollment target

NCT05587309 is a Phase 3 study that has completed, run by Braintree Laboratories. The registered enrollment target is 1,250 participants.

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The verdict

NCT05587309, a Phase 3 study, has completed, sponsored by Braintree Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
1,250 participants
Enrollment target

Study Summary

The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.

Interventions

  • DRUG BLI5100
  • DRUG PPI Control

Trial Details

FieldValue
Enrollment Target 1,250 participants
Start Date 2022-10-30
Est. Completion 2025-06-16
Phase Phase 3

Sponsor

Braintree Laboratories

49 total trials

What the Registry Record Tells You About NCT05587309

The ClinicalTrials.gov registry entry for NCT05587309 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Braintree Laboratories, which has 49 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which BLI5100 is the first listed.

NCT05587309 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05587309 about?

NCT05587309 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis". The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once dail...

What is the current status of trial NCT05587309?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2022-10-30. Estimated completion is 2025-06-16.

What interventions are being tested in trial NCT05587309?

The interventions under investigation include: BLI5100 (DRUG), PPI Control (DRUG).

Who is sponsoring clinical trial NCT05587309?

This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.