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Long-Term Safety of BLI5100 for Acid Reflux

Phase 3
Waitlist Available
Research Sponsored by Braintree Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights

Study Summary

This trial tests the safety of taking a drug daily for up to a year to treat acid reflux and healed esophagitis.

Who is the study for?
This trial is for patients with non-erosive reflux disease or healed erosive esophagitis who completed prior BLI5100 studies without serious issues. Participants must not be pregnant, use reliable birth control, and avoid certain medications like NSAIDs and antipsychotics.Check my eligibility
What is being tested?
The study tests the long-term safety of a daily oral medication called BLI5100 over a year. It's for those who've had acid reflux or esophagitis but are now in better condition after previous treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to BLI5100 during the trial to assess its long-term safety profile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 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
Frequency of treatment-emergent adverse events

Trial Design

2Treatment groups
Experimental Treatment
Group I: BLI5100 Low DoseExperimental Treatment1 Intervention
Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.
Group II: BLI5100 High DoseExperimental Treatment1 Intervention
Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.

Find a Location

Who is running the clinical trial?

Braintree LaboratoriesLead Sponsor
48 Previous Clinical Trials
13,124 Total Patients Enrolled
1 Trials studying Non-erosive Reflux Disease
800 Patients Enrolled for Non-erosive Reflux Disease

Media Library

BLI5100 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05890001 — Phase 3
Non-erosive Reflux Disease Research Study Groups: BLI5100 Low Dose, BLI5100 High Dose
Non-erosive Reflux Disease Clinical Trial 2023: BLI5100 Highlights & Side Effects. Trial Name: NCT05890001 — Phase 3
BLI5100 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05890001 — Phase 3

Frequently Asked Questions

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

Could I be a part of this research endeavor?

"Patients meeting the criteria for non-erosive reflux disease and falling between 18 and 85 years of age are eligible to take part in this clinical trial. Approximately 400 individuals need to be recruited."

Answered by AI

How many medical centers within the state are conducting this clinical investigation?

"This trial is accessible at 21 distinct medical centres, which are located in Phoenix, Huntington Park and Santa Ana plus 18 other cities. To reduce commuting costs for participants of this study it's best to select a clinic as close to your location as possible."

Answered by AI

Is the minimum age requirement of this study less than twenty years old?

"According to the set parameters, individuals between 18 and 85 are eligible for this clinical trial. For those who are younger than 18 or older than 65 years old there are 30 and 87 opportunities respectively."

Answered by AI

Are there any risks associated with taking BLI5100 Low Dose?

"The safety of BLI5100 Low Dose is judged to be a 3 on our internal scale, due to the numerous studies that have indicated its efficacy and established evidence for its general security."

Answered by AI

Are there any unfilled slots available in this research endeavor?

"Clinicaltrials.gov confirms that, since the most recent update on May 25th 2023, this medical research has stopped recruiting patients. Nevertheless, there are an additional 109 studies currently accepting enrollees at this time."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site 43
Research Site 06
Research Site 59
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I believe this might be beneficial for my health.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease
2023. "A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05890001.
All > Gerd
~200 spots leftby Apr 2025
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