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

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ClinicalTrials.gov Identifier: NCT01905202
Recruitment Status : Unknown
Verified August 2014 by Effexus Pharmaceutical.
Recruitment status was:  Enrolling by invitation
First Posted : July 23, 2013
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Effexus Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Drug: Secretrol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015

Arm Intervention/treatment
Experimental: Secretrol
Secretrol Capsules 80/80 once daily for 6 months
Drug: Secretrol



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Number of participants who develop C. difficile induced diarrhea [ Time Frame: Over 6 months ]

Other Outcome Measures:
  1. Gastrin 17 [ Time Frame: Baseline, Day 30, 6 months ]
    Serum Gastrin 17 will be measured and compared to baseline.

  2. Bile acids/salts [ Time Frame: Baseline, Day 30 ]
    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

  3. Serum calcium [ Time Frame: Baseline, 30 days and 6 months ]
  4. Serum magnesium [ Time Frame: Baseline, 30 days and 6 months ]
  5. 48 hour gastroesophageal pH measurement [ Time Frame: Baseline, 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905202


Locations
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United States, Missouri
Veteran's Administration Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Effexus Pharmaceutical
Investigators
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Principal Investigator: Prateek Sharma, M.D. Kansas City, Missouri VAMC

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Responsible Party: Effexus Pharmaceutical
ClinicalTrials.gov Identifier: NCT01905202     History of Changes
Other Study ID Numbers: EP404
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014
Keywords provided by Effexus Pharmaceutical:
Proton Pump Inhibitor
Safety
Tolerability
pH control
Bile Acid
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases