Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01905202
Other study ID # EP404
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received July 17, 2013
Last updated August 1, 2014
Start date April 2013

Study information

Verified date August 2014
Source Effexus Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 13
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Secretrol


Locations

Country Name City State
United States Veteran's Administration Medical Center Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Effexus Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Gastrin 17 Serum Gastrin 17 will be measured and compared to baseline. Baseline, Day 30, 6 months Yes
Other 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 No
Other Serum calcium Baseline, 30 days and 6 months Yes
Other Serum magnesium Baseline, 30 days and 6 months Yes
Other 48 hour gastroesophageal pH measurement Baseline, 30 days No
Primary Number of patients with adverse events at 6 months Yes
Secondary Number of participants who develop C. difficile induced diarrhea Over 6 months Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02864043 - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System N/A
Recruiting NCT02018367 - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma Phase 2
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
Suspended NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus
Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
Completed NCT02879721 - Expression and Function of the Renin-Angiotensin System in the Esophagus Phase 0
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A