Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)

Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)

Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.

Study Overview

• Status: Unknown
• Conditions: EMR Ulcer
• Intervention / Treatment: Drug: Secretrol

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Recruiting
      • Veteran's Administration Medical Center
      • Principal Investigator: Prateek Sharma, MD
      • Contact: Higbee, BSN; Phone Number: 57456 816-861-4700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Category 4-high-grade intraepithelial neoplasia
• Ages 18 or older
• signed Informed Consent Form
• signed Health Insurance Portability and Accountability Act (HIPAA) Authorization Form

Exclusion Criteria:

• Clinically relevant data suggesting an unknown disease and requiring further evaluation by the Primary Investigator.
• Patients with renal failure or organ transplants.
• Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).
• Participation in another study that would interfere with study endpoints within 30 days prior to screening.
• Previous enrollment into the current study.
• Patient is the Investigator, his family member or employee at the investigational site.
• Patient known or suspected to be involved in alcohol or drug abuse.
• Known or suspected history of non-compliance with medications.
• Inability to follow the procedures of the study (e.g., due to language problems, psychological disorders)
• Patients receiving prohibited concomitant medications including PPIs, H2-blockers, sucralfate, misoprostol.
• Patients receiving prohibited concomitant medications including 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.
• Pregnancy or intention to become pregnant during the course of study, breast feeding, or unwillingness to use a highly effective means of contraception (oral contraception or intrauterine device).
• Prescription Non-steroidal anti-inflammatory Drug (NSAID) or aspirin use: The patient must be able to stop these meds 1 week prior to screening and during treatment.
• History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility disorders, Inflammatory Bowel Disease (IBD), AIDS, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, liver disease, active malignant disease, Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy, functional bowel disorder or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time.
• Subject unable or unwilling to fully complete all stages of the study.
• Unable to sign informed consent or inability to give fully informed consent due to language problems, psychological disorder or mental deficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secretrol	Drug: Secretrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse effect evaluation	60 days

Collaborators and Investigators

• Sponsor: Effexus Pharmaceutical

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: EP202