Gastroesophageal Reflux Disease (GERD)Phase 1/2NCT01129713
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
A Phase 1/2 study testing Secretol and Nexium in people with Gastroesophageal Reflux Disease (GERD) and Heartburn, run by Effexus Pharmaceutical at 1 site in United States.
Trial summary
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Heartburn, Indigestion
- What is being tested?
- Secretol and Nexium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2015
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages 18-75
- EE Los Angeles grades C or D
- Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
- Able to read, understand, and complete study questionnaires and record
- Able to understand the study procedures and sign informed consent
- Able to comply with all study requirements
Who cannot join
- Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Subjects with clinically significant underlying comorbidity
- Helicobacter pylori positive
- Clinically significant GI bleed within the last 3 months
- Esophagitis not related to acid reflux
Show all 12Show fewer
- Bleeding disorder
- Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
- Women pregnant or lactating
- History of allergic reaction to any Proton Pump Inhibitor (PPI)
- Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS > 3 times/week
- Any medication dependant on gastric acid for optimal absorption
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southern Arizona Veterans Health Care System
Tucson, Arizona, 85723
Ronnie Fass, MD
About this study
Official title: Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
Read the detailed description
We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.
- Being tested
- Secretol, Nexium
- Keywords
- GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretolDrug
Also called lansoprazole/omeprazole combination
Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
NexiumDrug
Also called Esomeprazole
Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.
| Study group | Role | What they receive |
|---|---|---|
| Nexium | Active comparator | Comparing 40 mg.once daily in healing erosive esophagitis. Receives: Drug: Nexium |
| Secretol | Active comparator | Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis. Receives: Drug: Secretol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to evaluate the relationship between healing and study drug allotment.
The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD.
Measured: 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Effexus Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Arizona VA Health Care System
- Responsible party
- Sponsor
- Investigators
- Ronnie Fass, MD, Principal investigator, Southern Arizona VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129713
- Sponsor's protocol ID
- NEXIUM versus SECRETOL
- Status last verified
- Aug 2014
- First submitted
- 24 May 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
- ClinicalTrials.gov ID
- NCT01129713
- Acronym / sponsor ID
- NEXIUM versus SECRETOL
- Keywords
- GERD, Acid Reflux, Heartburn, Regurgitation, Indigestion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Effexus PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Southern Arizona VA Health Care System
- Study start
- May 2010
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 25 May 2010 (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.
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
Detailed description
We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nexium | Active comparator | Drug: NexiumComparing 40 mg.once daily in healing erosive esophagitis. |
| Secretol | Active comparator | Drug: SecretolComparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female
- Ages 18-75
- EE Los Angeles grades C or D
- Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
- Able to read, understand, and complete study questionnaires and record
Key exclusion criteria (12 listed)
- Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Subjects with clinically significant underlying comorbidity
- Helicobacter pylori positive
- Clinically significant GI bleed within the last 3 months
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 |
|---|---|---|
| SecretolAlso: lansoprazole/omeprazole combinationComparing 80/80 once daily to Nexium once daily in healing erosive esophagitis. | Drug | Secretol |
| NexiumAlso: EsomeprazoleComparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis. | Drug | Nexium |
Primary outcome
Primary objective is to evaluate the relationship between healing and study drug allotment.
Time frame: 3 weeks of treatment
The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Related trials for Gastroesophageal Reflux Disease (GERD)
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Ronnie Fass, MD principal investigator
Southern Arizona VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Secretol and Nexium in people with Gastroesophageal Reflux Disease (GERD) and Heartburn, 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 7 inclusion and 12 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 5 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ronnie Fass, MD (520-792-1450 ext. 5139, ronnie.fass@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective is to evaluate the relationship between healing and study drug allotment. (time frame: 3 weeks of treatment). 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 5 Aug 2014.