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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a high-grade precancerous condition.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse effect evaluation
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney failure or have had an organ transplant.I am not taking PPIs, H2-blockers, sucralfate, or misoprostol.I am not taking any medications that are not allowed in the study.I have a history of serious digestive, heart, lung, liver diseases, or diabetes.I am willing and able to complete all parts of the study.I have a high-grade precancerous condition.I can stop taking NSAIDs or aspirin one week before and during the treatment.I am 18 years old or older.
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.
Are new participants still welcome to join this experiment?
"The trial in question, which was initially posted on April 1st 2013 and last updated on August 4th 2014 is not presently enrolling patients. However, there are one other medical studies that have opened their recruitment process to the public."
Answered by AI
Has the FDA sanctioned Secretrol for use?
"As Secretrol is still in its initial Phase 1 trial, the safety of this drug has been scored at a 1 due to limited data on both efficacy and safety."
Answered by AI
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