Barrett's EsophagusPhase 1NCT01905202
The Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
A Phase 1 study testing Secretrol in people with Barrett's Esophagus, run by Effexus Pharmaceutical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Secretrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran's Administration Medical Center
Kansas City, Missouri, 64128
About this study
Official title: 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.
Read the 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.
- Conditions
- Barrett's Esophagus
- Being tested
- Secretrol
- Keywords
- Proton Pump Inhibitor, Safety, Tolerability, pH control, Bile Acid
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretrolDrug
| Study group | Role | What they receive |
|---|---|---|
| Secretrol | Experimental | Secretrol Capsules 80/80 once daily for 6 months Receives: Drug: Secretrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: at 6 months
Secondary outcomes (1)
Number of participants who develop C. difficile induced diarrhea
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Effexus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prateek Sharma, M.D., Principal investigator, Kansas City, Missouri VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905202
- Sponsor's protocol ID
- EP404
- Status last verified
- Aug 2014
- First submitted
- 17 Jul 2013
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety and Tolerability of Secretrol in Patients With Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01905202
- Acronym / sponsor ID
- EP404
- Conditions
- Barrett's Esophagus
- Keywords
- Proton Pump Inhibitor, Safety, Tolerability, pH control, Bile Acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Effexus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secretrol | Experimental | Drug: SecretrolSecretrol Capsules 80/80 once daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secretrol | Drug | Secretrol |
Primary outcome
Number of patients with adverse events
Time frame: at 6 months
1 secondary outcome
Number of participants who develop C. difficile induced diarrhea
Time frame: Over 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prateek Sharma, M.D. principal investigator
Kansas City, Missouri VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Secretrol in people with Barrett's Esophagus, run by Effexus Pharmaceutical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.