Recruiting
Phase 1

Secretrol®

Sponsor:

Effexus Pharmaceutical

Code:

NCT02210494

Conditions

EMR Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Secretrol

Study Details

Brief summary:

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

Conditions

EMR Ulcer

Study ID

NCT02210494

Start date

Apr, 2013

Status verified date

Aug, 2014

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Secretrol

Interventions

Secretrol

Primary outcome measure

  • Adverse effect evaluation [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

April Higbee, BSN

816 861-4700April.Higbee@va.gov

Locations

Veteran's Administration Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Higbee, BSN

816-861-4700

Principal Investigator:

Prateek Sharma, MD

More Information

Sponsor

Effexus Pharmaceutical

Last update posted

Aug 6, 2014

Last verified

Aug, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Effexus Pharmaceutical on 2014-08-06.