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

NCT02210494 | Unknown Phase 1 DMC

• 1 other identifier: EP202
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

EMR Ulcer

Outcome Measures

Primary Outcomes (1)

• Adverse effect evaluation

  60 days

Study Arms (1)

Secretrol

EXPERIMENTAL

Drug: Secretrol

Interventions

Secretrol DRUG

Secretrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Effexus Pharmaceutical: lead

Study Sites (1)

Veteran's Administration Medical Center

Kansas City, Missouri, 64128, United States

RECRUITING

Central Study Contacts

April Higbee, BSN

CONTACT

816 861-4700; April.Higbee@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 6, 2014
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (1)