EMR UlcerPhase 1NCT02210494
Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
A Phase 1 study testing Secretrol in people with EMR Ulcer, run by Effexus Pharmaceutical at 1 site in United States.
Trial summary
Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EMR Ulcer
- What is being tested?
- Secretrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 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
- Category 4-high-grade intraepithelial neoplasia
- Ages 18 or older
- signed Informed Consent Form
- signed 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.
- Patients with renal failure or organ transplants.
- Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).
- Participation in another study that would interfere with study endpoints 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.
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- 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, misoprostol.
- Patients receiving prohibited concomitant medications including 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).
- Prescription Non-steroidal anti-inflammatory Drug (NSAID) or aspirin use: The patient must be able to stop these meds 1 week prior to screening and during treatment.
- History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility disorders, Inflammatory Bowel Disease (IBD), AIDS, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, liver disease, active malignant disease, Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy, functional bowel disorder or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time.
- Subject 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, 1 recruiting
- Recruiting
Veteran's Administration Medical Center
Kansas City, Missouri, 64128
Higbee, BSN, 816-861-4700 ext. 57456
Prateek Sharma, MD
About this study
Official title: Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.
- Conditions
- EMR Ulcer
- Being tested
- Secretrol
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 | Not described Receives: Drug: Secretrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effect evaluation
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EMR UlcerStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Effexus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210494
- Sponsor's protocol ID
- EP202
- Status last verified
- Aug 2014
- First submitted
- 1 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)
- ClinicalTrials.gov ID
- NCT02210494
- Acronym / sponsor ID
- EP202
- Conditions
- EMR Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Effexus PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 6 Aug 2014 (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.
Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for early adenocarcinoma of the esophagus.
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: Secretrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Category 4-high-grade intraepithelial neoplasia
- Ages 18 or older
- signed Informed Consent Form
- signed Health Insurance Portability and Accountability Act (HIPAA) Authorization Form
Key exclusion criteria (16 listed)
- Clinically relevant data suggesting an unknown disease and requiring further evaluation by the Primary Investigator.
- Patients with renal failure or organ transplants.
- Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).
- Participation in another study that would interfere with study endpoints within 30 days prior to screening.
- Previous enrollment into the current study.
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
Adverse effect evaluation
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
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 EMR Ulcer, 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 4 inclusion and 16 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 6 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?
Contact April Higbee, BSN (816 861-4700 ext. 57456, April.Higbee@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effect evaluation (time frame: 60 days). 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 6 Aug 2014.