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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥18 years at the time of signing informed consent
Have documented history of symptomatic GERD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial will evaluate the safety & efficacy of oral BLI5100 given daily for 4 wks, then safety for 20 wks, for those with NERD.
Who is the study for?
Adults with Non-erosive Reflux Disease (NERD) who've had heartburn for at least 6 months, no esophageal damage on endoscopy, and not using certain medications. Men must use birth control or abstain from sperm donation for 3 months post-trial; women must be non-childbearing or use birth control.Check my eligibility
What is being tested?
The trial tests BLI5100's safety and effectiveness in treating NERD over four weeks compared to a placebo. Participants will receive either a low dose, high dose of BLI5100, or a placebo once daily. There's also an extension phase to assess long-term safety.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical drug reactions such as digestive issues, allergic responses, headaches, fatigue or other symptoms based on the individual's reaction to the medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have a history of severe acid reflux.
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I have a history of severe acid reflux.
Select...
I've had heartburn on 4 or more days in a week recently.
Select...
I've experienced heartburn on 4 or more days in a week recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of 24-hour heartburn-free days
Secondary outcome measures
Heartburn
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BLI5100 Low DoseExperimental Treatment1 Intervention
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.
Group II: BLI5100 High DoseExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Braintree LaboratoriesLead Sponsor
48 Previous Clinical Trials
12,724 Total Patients Enrolled
1 Trials studying Non-erosive Reflux Disease
400 Patients Enrolled for Non-erosive Reflux Disease
Leah HollinsStudy DirectorBraintree Laboratories / Sebela Pharmaceuticals
1 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any acid-reducing medication in the last 2 weeks.I am 18 years old or older.I must continue taking NSAIDs throughout the study.I am either not able to have children or will use birth control during the study.I have a condition that causes excessive stomach acid.I am 18 years old or older.You have a history of allergic reactions or are intolerant to the active ingredient or other ingredients in the study drug.I have a history of severe acid reflux.I agree to use birth control from the start of the study until 3 months after the last dose.I understand and can follow the study's requirements.I agree not to donate sperm for 3 months after my last dose of the study drug.You have a history of mental health conditions like bipolar disorder, anxiety disorder, panic disorder, or other psychological disorders.I have a history of severe acid reflux.I have been on a stable dose of mental health or sleeping medication for over 6 months.I was diagnosed with a serious stomach or esophagus issue in the last 2 months.I cannot have children due to surgery or menopause, or I agree to use birth control during the study.I've had heartburn on 4 or more days in a week recently.I have had heartburn for at least 6 months.I haven't had severe swallowing issues, bleeding, weight loss, anemia, or bloody stools in the last month, or these symptoms have been checked and are not due to cancer.I have issues like strictures, bleeding, or ulcers in my upper GI tract.I haven't had cancer in the past 5 years, except for treated skin cancer.I have taken 2 or more doses of acid reflux medication in the week before my upper GI endoscopy.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I agree to use birth control from the start of the study until 3 months after the last dose.I agree not to donate sperm for 3 months after my last dose of the study drug.I have had surgery related to acid reflux or on my esophagus/stomach.I have a history of connective tissue disorder with GI symptoms or inflammatory bowel disease.I've experienced heartburn on 4 or more days in a week recently.I have or might have a digestive system disorder.I understand and can follow the study's requirements.I cannot have an upper GI endoscopy.I have had heartburn for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: BLI5100 High Dose
- Group 2: Placebo
- Group 3: BLI5100 Low Dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-erosive Reflux Disease Patient Testimony for trial: Trial Name: NCT05587322 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly patients being recruited for this phase of the research?
"Eligibility for this specific study is restricted to patients that are between 18-85 years old. There are 14 other studies available for minors and 57 research trials open to seniors."
Answered by AI
Is this clinical trial taking place in more than one city?
"There are 26 clinical trial sites currently running this study, located in Houma, Great Neck, San Antonio, and other places."
Answered by AI
How many test subjects are enrolled in this clinical trial?
"The information available on clinicaltrials.gov does indicate that this study is currently looking for enrolment from eligible patients. This particular trial was first posted on September 6th, 2020 and has since been updated October 17th, 2020. There are 26 proposed locations where the research will be conducted and they are recruiting for a total of 633 individuals."
Answered by AI
Could I potentially join this clinical trial based on my medical history?
"This clinical trial is recruiting 633 patients with non-erosive reflux disease aged 18 and 85. Candidates should meet the following criteria: 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 e"
Answered by AI
Is BLI5100 Low Dose an FDA-regulated medication?
"BLI5100 Low Dose received a safety score of 3 from our team at Power. This is due to the fact that this medication is in Phase 3 trials, which means that there is both efficacy and safety data available."
Answered by AI
Are patients still being recruited for this study?
"Yes, as of right now the trial is looking for 633 patients to enroll at 26 different sites. The website provides information that the study was posted on September 6th and updated last on October 17th of this year."
Answered by AI
Who else is applying?
What site did they apply to?
Research Site 06
Research Site 66
Research Site 59
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Colorado
Nevada
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Most drugs don't work. My mom died of esophagus cancer.
PatientReceived 2+ prior treatments
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