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

Phase 1 Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus

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.

Study Overview

• Status: Unknown
• Conditions: Barrett's Esophagus
• Intervention / Treatment: Drug: Secretrol

Detailed Description

A majority of patients with Barrett's esophagus have poor distal esophageal pH control. Such patients frequently receive more than one dose of PPI per day in an attempt to improve esophageal pH control. Nocturnal pH control is notably difficult to achieve in many patients suffering from Barrett's esophagus. Recently, adverse effects have been associated with prolonged PPI use (defined as 1 year or longer). These include hypomagnesemia, bone fractures, Clostridium difficile induced diarrhea. High dose PPI as well as very high dose PPI usage (such as that used in hypersecretory conditions) has generally not been found to produce a different side effect or tolerability profile in humans. This study will evaluate the effects of Secretrol on tolerability, adverse effects and pH control of the distal esophagus and just below the squamocolumnar junction.

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Veteran's Administration Medical Center

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:

• 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.

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; Secretrol Capsules 80/80 once daily for 6 months	Drug: Secretrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants who develop C. difficile induced diarrhea	Over 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrin 17	Serum Gastrin 17 will be measured and compared to baseline.	Baseline, Day 30, 6 months
Bile acids/salts	Bile acids and bile salts can be affected by pH changes. The differential characterization of bile acid and bile salts will be performed at Baseline as compared to Day 30	Baseline, Day 30
Serum calcium		Baseline, 30 days and 6 months
Serum magnesium		Baseline, 30 days and 6 months
48 hour gastroesophageal pH measurement		Baseline, 30 days

Collaborators and Investigators

• Sponsor: Effexus Pharmaceutical
• Investigators: Principal Investigator: Prateek Sharma, M.D., Kansas City, Missouri VAMC

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Proton Pump Inhibitor; Bile Acid; pH control
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: EP404