This trial studies safety & efficacy of a drug (BLI5100) in healing & maintaining healed EE over 8 weeks & 24 weeks, respectively.
- Erosive Esophagitis
2 Primary · 2 Secondary · Reporting Duration: 24 Weeks
5 Treatment Groups
Healing Phase - PPI Control
1 of 5
Maintenance Phase - PPI Control
1 of 5
Healing Phase - BLI5100
1 of 5
Maintenance Phase - BLI5100 Low Dose
1 of 5
Maintenance Phase - BLI5100 High Dose
1 of 5
1250 Total Participants · 5 Treatment Groups
Primary Treatment: Healing Phase - BLI5100 · No Placebo Group · Phase 3
Who is running the clinical trial?
Age 18 - 85 · All Participants · 8 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor