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Secretrol® Safety for Esophageal Cancer

Phase 1
Waitlist Available
Research Sponsored by Effexus Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Category 4-high-grade intraepithelial neoplasia
Ages 18 or older
Must not have
Patients with renal failure or organ transplants
Patients receiving prohibited concomitant medications including PPIs, H2-blockers, sucralfate, misoprostol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.

Who is the study for?
This trial is for adults with high-grade intraepithelial neoplasia undergoing EMR. Participants must not be related to the study team, have a history of medication non-compliance, or use certain medications like PPIs and NSAIDs. They can't join if they're pregnant, breastfeeding, planning pregnancy without effective contraception, have renal failure or organ transplants, known allergies to PPIs, a history of substance abuse or significant health issues affecting the esophagus.
What is being tested?
The trial tests Secretrol's safety in patients having an endoscopic mucosal resection (EMR) for early esophageal adenocarcinoma. It aims to see how well patients tolerate Secretrol and monitor any adverse effects during short-term management post-EMR.
What are the potential side effects?
While specific side effects of Secretrol are not listed here, common ones may include digestive discomforts such as nausea or abdominal pain; allergic reactions; potential interactions with other drugs; and possible changes in liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a high-grade precancerous condition.
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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 PPIs, H2-blockers, sucralfate, or misoprostol.
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I am not taking any medications that are not allowed in the study.
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I am willing and able to complete all parts of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SecretrolExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Effexus PharmaceuticalLead Sponsor
2 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Secretrol Clinical Trial Eligibility Overview. Trial Name: NCT02210494 — Phase 1
EMR Ulcer Research Study Groups: Secretrol
EMR Ulcer Clinical Trial 2023: Secretrol Highlights & Side Effects. Trial Name: NCT02210494 — Phase 1
Secretrol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02210494 — Phase 1
~0 spots leftby Nov 2025
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