Gastroesophageal Reflux DiseasePhase 4NCT00251732
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
A Phase 4 study testing Standard dose (once daily) PPI plus low-dose antidepressant in people with Gastroesophageal Reflux Disease, run by University of Arizona at 1 site in United States.
Trial summary
The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Standard dose (once daily) PPI plus low-dose antidepressant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2010
- Phase
- Phase 4
- 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 to 75
- At least two episodes of heartburn per week while on PPI once daily
- Able to communicate with the investigator and comply with the requirements of the study
- Subjects who give written informed consent after being given a full description of the study.
Who cannot join
- Known allergy or intolerance to TCA
- Use of antidepressant or a diagnosis of depression
- History of serious arrhythmia or use of anti-arrhythmics
- History of seizures
- Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
- Evidence or history of drug abuse within the past 6 months
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- Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
- History of esophagogastric surgery
- Gastric or duodenal lesions (ulcer, tumor, etc)
- Women who are pregnant or of childbearing age who are not on contraception
- Patients who are unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
Read the detailed description
To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Standard dose (once daily) PPI plus low-dose antidepressant, Double dose PPI plus evening placebo, Rabeprazole , placebo, placebo
- Keywords
- acid reflux studies, efficacy of PPI therapy, failing PPI therapy, GERD, Acid Reflux Disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dose (once daily) PPI plus low-dose antidepressantDrug
Also called Aciphex-PPI, Nortriptyline-TCA
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Double dose PPI plus evening placeboDrug
Also called Aciphex-PPI, rabeprazole
20 mg. twice daily with a placebo
Rabeprazole , placebo, placeboDrug
Also called Aciphex-rabeprazole (PPI), Nortriptyline-low-dose tricyclic antidepressant (TCA)
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
| Study group | Role | What they receive |
|---|---|---|
| Standard dose (PPI) plus low dose TCA | Active comparator | Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA) Receives: Drug: Standard dose (once daily) PPI plus low-dose antidepressant |
| Double dose PPI | Active comparator | Double dose proton pump inhibitor plus placebo Receives: Drug: Double dose PPI plus evening placebo |
| Standard dose PPI plus placebo x 2 | Placebo comparator | Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime Receives: Drug: Rabeprazole , placebo, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom control after 6 weeks of treatment
To measure the outcome after 6 weeks of treatment
Measured: 6 weeks
Secondary outcomes (3)
Number of drop-outs due to poor symptom control
To measure the number of drop-outs due to poor symptom control.
Measured: 6 weeks
Level of antacid consumption
To measure the level of antacid consumption due to poor symptom control.
Measured: 6 weeks
Improvement in quality of life
To improve quality of life with GERD symptom control.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Arizona VA Health Care System, Janssen Pharmaceutica N.V., Belgium
- Investigators
- Ronnie Fass, MD, Principal investigator, SAVAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251732
- Sponsor's protocol ID
- Merit Review Study
- Status last verified
- Aug 2010
- First submitted
- 8 Nov 2005
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
- ClinicalTrials.gov ID
- NCT00251732
- Acronym / sponsor ID
- Merit Review Study
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- acid reflux studies, efficacy of PPI therapy, failing PPI therapy, GERD, Acid Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Southern Arizona VA Health Care System, Janssen Pharmaceutica N.V., Belgium
- Study start
- Mar 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 2005 (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.
The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
Detailed description
To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dose (PPI) plus low dose TCA | Active comparator | Drug: Standard dose (once daily) PPI plus low-dose antidepressantStandard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA) |
| Double dose PPI | Active comparator | Drug: Double dose PPI plus evening placeboDouble dose proton pump inhibitor plus placebo |
| Standard dose PPI plus placebo x 2 | Placebo comparator | Drug: Rabeprazole , placebo, placeboStandard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Ages 18 to 75
- At least two episodes of heartburn per week while on PPI once daily
- Able to communicate with the investigator and comply with the requirements of the study
- Subjects who give written informed consent after being given a full description of the study.
Key exclusion criteria (11 listed)
- Known allergy or intolerance to TCA
- Use of antidepressant or a diagnosis of depression
- History of serious arrhythmia or use of anti-arrhythmics
- History of seizures
- Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
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 |
|---|---|---|
| Standard dose (once daily) PPI plus low-dose antidepressantAlso: Aciphex-PPI, Nortriptyline-TCA20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA) | Drug | Standard dose (PPI) plus low dose TCA |
| Double dose PPI plus evening placeboAlso: Aciphex-PPI, rabeprazole20 mg. twice daily with a placebo | Drug | Double dose PPI |
| Rabeprazole , placebo, placeboAlso: Aciphex-rabeprazole (PPI), Nortriptyline-low-dose tricyclic antidepressant (TCA)20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime | Drug | Standard dose PPI plus placebo x 2 |
Primary outcome
Symptom control after 6 weeks of treatment
Time frame: 6 weeks
To measure the outcome after 6 weeks of treatment
3 secondary outcomes
Number of drop-outs due to poor symptom control
Time frame: 6 weeks
Level of antacid consumption
Time frame: 6 weeks
Improvement in quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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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.
Ronnie Fass, MD principal investigator
SAVAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard dose (once daily) PPI plus low-dose antidepressant in people with Gastroesophageal Reflux Disease, run by University of Arizona 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 19 Aug 2010. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom control after 6 weeks of treatment (time frame: 6 weeks). 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 19 Aug 2010.