The Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be safe and well tolerated. Further, pH control will be evaluated in the distal esophageal mucosa and just below the squamocolumnar junction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Effexus Pharmaceutical

Criteria

Inclusion Criteria:

• Barrett's esophagus with histological confirmed Barrett's ≥ 2 cm in length and negative or indefinite for dysplasia/neoplasia.

• Ages 18 and older.

• Patients who have signed an Informed Consent Form and 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.

• If you have a pacemaker, cardiac defibrillator or neurostimulator.

• Patients with renal failure or organ transplants.

• Patients who have known allergic reactions to Proton Pump Inhibitors.

• Participation in another study 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, misoprostil. Note: patient to take dose of "usual" PPI medication in morning of visit 2 and continue for the next 24 hours. After that no PPI is permitted (except Secretrol)

• Patients receiving prohibited concomitant medications including theophylline, 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).

• Unable to complete 48-hr esophageal pH monitoring.

• Prescription NSAID use or aspirin use greater than 325mg daily.

• History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility disorders, IBD, AIDS, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, liver disease, active malignant disease, scleroderma, autonomic or peripheral neuropathy, myopathy, any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time.

• Were 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.