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Secretrol for Barrett's Esophagus
Phase 1
Waitlist Available
Led By Prateek Sharma, M.D.
Research Sponsored by Effexus Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Barrett's esophagus with histologically confirmed Barrett's ≥ 2 cm in length and negative or indefinite for dysplasia/neoplasia
Ages 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new medication for Barrett's Esophagus, a condition where the lining of the esophagus changes.
Who is the study for?
This trial is for adults with Barrett's Esophagus, confirmed to be at least 2 cm long without severe dysplasia or cancer. Participants must understand and sign consent forms, not have pacemakers or certain medical conditions, avoid specific medications like PPIs (except Secretrol), and not be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The study tests the safety of a drug called Secretrol over six months in patients with Barrett's Esophagus. It will also assess how well it controls acid levels in the lower esophagus.See study design
What are the potential side effects?
While specific side effects are not listed here, similar drugs often cause digestive issues such as nausea, headaches, diarrhea, abdominal pain, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Barrett's esophagus longer than 2 cm without cancerous changes.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with adverse events
Secondary outcome measures
Number of participants who develop C. difficile induced diarrhea
Other outcome measures
48 hour gastroesophageal pH measurement
Bile acids/salts
Gastrin 17
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SecretrolExperimental Treatment1 Intervention
Secretrol Capsules 80/80 once daily for 6 months
Find a Location
Who is running the clinical trial?
Effexus PharmaceuticalLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Prateek Sharma, M.D.Principal InvestigatorKansas City, Missouri VAMC
1 Previous Clinical Trials
98 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are not allowed in the study, except for a specific PPI dose as instructed.I have Barrett's esophagus longer than 2 cm without cancerous changes.I am 18 years old or older.I am willing and able to complete all parts of the study.I have kidney failure or have had an organ transplant.I am not taking any medications that are not allowed in the study.I take more than 325mg of aspirin or NSAIDs daily.I have a history of serious digestive, heart, lung, liver diseases, or conditions affecting my esophagus.
Research Study Groups:
This trial has the following groups:- Group 1: Secretrol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards should individuals be aware of before taking Secretrol?
"Our panel at Power gave Secretrol a score of 1 due to its Phase 1 status, indicating that there is only minimal data available regarding the medication's efficacy and safety."
Answered by AI
Are recruitment efforts underway for this trial?
"Judging by the data hosted on clinicaltrials.gov, there is no active recruitment for this trial; its initial posting was dated April 1st 2013 and it has not been updated since August of 2014. Though, 36 other medical studies are actively seeking participants at present."
Answered by AI
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