NCT01905202

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

July 17, 2013

Last Update Submit

August 1, 2014

Conditions

Barrett's Esophagus

Keywords

Proton Pump InhibitorSafetyTolerabilitypH controlBile Acid

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    at 6 months

Secondary Outcomes (1)

  • Number of participants who develop C. difficile induced diarrhea

    Over 6 months

Other Outcomes (5)

  • Gastrin 17

    Baseline, Day 30, 6 months

  • Bile acids/salts

    Baseline, Day 30

  • Serum calcium

    Baseline, 30 days and 6 months

  • +2 more other outcomes

Study Arms (1)

Secretrol

EXPERIMENTAL

Secretrol Capsules 80/80 once daily for 6 months

Drug: Secretrol

Interventions

SecretrolDRUG
Secretrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran's Administration Medical Center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Prateek Sharma, M.D.

    Kansas City, Missouri VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 23, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

US(1)