Clinical trial NCT02210494: Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
Official title: Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: EMR Ulcer
Lead sponsor: Effexus Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse effect evaluation
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Veteran's Administration Medical Center
state: Missouri
Study officials:
References: