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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
Must not have
Patients with renal failure or organ transplants
Receiving prohibited concomitant medications including theophylline, clopidogrel, ketoconazole, digoxin, diazepam, warfarin, phenytoin, emtricitabine/nelfinavir/tenofovir, atazanavir, citalopram, emtricitabine/rilpivirine/tenofovir, rilpivirine, nelfinavir, tricyclic antidepressants, baclofen, tacrolimus, cyclosporine, cilostazol, disulfiram, methotrexate, voriconazole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 30, 6 months
Awards & highlights

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.
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.
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 below
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I have Barrett's esophagus longer than 2 cm without cancerous changes.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have kidney failure or have had an organ transplant.
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I am not taking any medications that are not allowed in the study.
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I take more than 325mg of aspirin or NSAIDs daily.
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I am willing and able to complete all parts of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 30, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 30, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Bile acids/salts
Gastrin 17

Trial 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

Secretrol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01905202 — Phase 1
Barrett's Esophagus Research Study Groups: Secretrol
Barrett's Esophagus Clinical Trial 2023: Secretrol Highlights & Side Effects. Trial Name: NCT01905202 — Phase 1
Secretrol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01905202 — Phase 1
~1 spots leftby Sep 2025
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