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Unknown

BLI5100 for Erosive Esophagitis

Verified Trial
Phase 3
Recruiting
Research Sponsored by Braintree Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial studies safety & efficacy of a drug (BLI5100) in healing & maintaining healed EE over 8 weeks & 24 weeks, respectively.

Who is the study for?
Adults with recent symptoms of heartburn and regurgitation, diagnosed with Erosive Esophagitis (EE) grades A to D. Participants must be able to consent and follow the study plan. Women should either be non-childbearing or agree to use birth control; men must also agree to use contraception and not donate sperm during the trial.Check my eligibility
What is being tested?
The trial is testing BLI5100 against a standard Proton Pump Inhibitor (PPI) for healing EE over 8 weeks, then maintaining healed EE over 24 weeks. Patients will take oral doses daily, comparing BLI5100's effectiveness and safety with PPI control.See study design
What are the potential side effects?
While specific side effects are not listed here, they may include typical reactions associated with gastrointestinal drugs such as digestive disturbances, potential allergic reactions or sensitivities related to the active ingredients or excipients in BLI5100.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had heartburn and regurgitation in the past week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Healing Phase: Percentage of patients with complete healing by Week 8.
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
Secondary outcome measures
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.
Heartburn

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Phase - BLI5100 Low DoseExperimental Treatment1 Intervention
During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
Group II: Maintenance Phase - BLI5100 High DoseExperimental Treatment1 Intervention
During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
Group III: Healing Phase - BLI5100Experimental Treatment1 Intervention
During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
Group IV: Healing Phase - PPI ControlActive Control1 Intervention
During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
Group V: Maintenance Phase - PPI ControlActive Control1 Intervention
During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.

Find a Location

Who is running the clinical trial?

Braintree LaboratoriesLead Sponsor
48 Previous Clinical Trials
12,274 Total Patients Enrolled
Leah HollinsStudy DirectorBraintree Laboratories / Sebela Pharmaceuticals
1 Previous Clinical Trials
800 Total Patients Enrolled

Media Library

BLI5100 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05587309 — Phase 3
Condition Research Study Groups: Healing Phase - BLI5100, Healing Phase - PPI Control, Maintenance Phase - BLI5100 Low Dose, Maintenance Phase - BLI5100 High Dose, Maintenance Phase - PPI Control
Condition Clinical Trial 2023: BLI5100 Highlights & Side Effects. Trial Name: NCT05587309 — Phase 3
BLI5100 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587309 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions for who can join this clinical trial?

"We are looking for 1250 individuals aged 18-85 who have erosive esophagitis and meet the following criteria:-Have experienced heartburn and regurgitation within the last 7 days-Able to understand and comply with the protocol requirements-Aged ≥18 years old and able to provide written informed consent-If female, must be of non-childbearing potential or willing to use an acceptable form of birth control-If male, must be willing to use an acceptable form of birth control and abstain from sperm donation-Current evidence of EE of LA grades A to"

Answered by AI

Do many North American clinics participate in this research?

"Currently, this study is being conducted at 26 different research sites, which are located in places such as Great Neck, Sunrise, and Palmetto Bay."

Answered by AI

Does this research include individuals older than 25 years old?

"This study's age requirements state that patients must be at least 18 years old but no older than 85 in order to be eligible for participation."

Answered by AI

Are investigators still signing up patients for this research?

"That is correct. The information available on clinicaltrials.gov tells us that this particular trial is ongoing and actively recruiting patients. This trial was first posted on November 30th, 2020 and was last updated on October 17th, 2020. They are looking for a total of 1250 participants from 26 different sites."

Answered by AI

Has the FDA cleared Maintenance Phase - BLI5100 High Dose for use?

"Maintenance Phase - BLI5100 High Dose falls into the third and final stage of clinical trials. This means that while there is some efficacy data, there is also a considerable amount of safety data. As a result, our team has given it a score of 3."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site 10
Research Site 114
Clinical Trials Management - Northshore
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I'm hoping to find a new medicine to eliminate my gerd. I've been dealing with esophagitis for years now , taken different meds but nothing has helped.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Clinical Trials Management - Northshore: < 48 hours
  2. Tandem Clinical Research, Houma: < 48 hours
  3. Tandem Clinical Research, Metairie: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
2022. "A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587309.
~125 spots leftby Jun 2024
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