Clinical trial NCT01905202: The Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
Official title: Phase 1 Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Barrett's Esophagus
Keywords: Proton Pump Inhibitor
Safety
Tolerability
pH control
Bile Acid
Lead sponsor: Effexus Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 13
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: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: at 6 months
Secondary outcomes:
measure: Number of participants who develop C. difficile induced diarrhea
timeFrame: Over 6 months
Other outcomes:
measure: Gastrin 17
timeFrame: Baseline, Day 30, 6 months
measure: Bile acids/salts
timeFrame: Baseline, Day 30
measure: Serum calcium
timeFrame: Baseline, 30 days and 6 months
measure: Serum magnesium
timeFrame: Baseline, 30 days and 6 months
measure: 48 hour gastroesophageal pH measurement
timeFrame: Baseline, 30 days
Locations:
city: Kansas City
country: United States
facility: Veteran's Administration Medical Center
state: Missouri
Study officials:
affiliation: Kansas City, Missouri VAMC
name: Prateek Sharma, M.D.
role: PRINCIPAL_INVESTIGATOR
References: