Gastroesophageal Reflux DiseaseNCT00057174
Economic Impact of Guidelines for Gastroesophageal Reflux Disease
A study testing Disease management of gastroesophageal reflux disease in people with Gastroesophageal Reflux Disease and Health Economics, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Health Economics
- What is being tested?
- Disease management of gastroesophageal reflux disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2004
- Phase
- Interventional
- 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
- Patients with GERD symptoms treated with PPIs. For the purpose of this study, GERD symptoms include heartburn or acid regurgitation. Symptoms of dyspepsia (epigastric pain, nausea, bloating, early satiety) may be present, but may not be used as the sole criteria for inclusion into the study.
- Asymptomatic (no heartburn or acid regurgitation) on PPI therapy.
Who cannot join
- Complications of gastroesophageal reflux disease including esophageal stricture, hemorrhage due to erosive esophagitis, Barrett�s esophagus or adenocarcinoma of the esophagus, or extra-esophageal manifestations of reflux disease (pulmonary or laryngeal disease due to acid reflux).
- Concurrent diagnoses of other gastrointestinal diseases including gastric or duodenal ulcer, Zollinger-Ellison syndrome or other hypersecretory disorders, or gastric cancer.
- Esophagitis secondary to non-acid peptic causes: infections (viral, bacterial, fungal), or medications causing esophageal erosions.
- Inability to maintain follow-up, either due to excessive distance to the VA primary care facility or lack of telephone services.
- Unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.
Read the detailed description
Background:
This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.
Objectives:
The objectives of this project are to determine the efficacy of step-down therapy and intermittent therapy in patients with GERD, and the impact of these strategies on direct healthcare costs and health-related quality of life (HRQOL). Additionally, we will examine patient factors predictive of non-response to these management strategies that may be alternatives to traditional continuous PPI administration.
Methods:
Two separate studies were conducted in our population of patients with GERD symptoms (heartburn or acid regurgitation) rendered asymptomatic on PPIs. Both studies randomized subjects to an intervention strategy (Step-down or Intermittent therapy) or to a control group in which PPIs were continued on a daily basis.
Step-down therapy: Step-down subjects discontinued PPIs and were prescribed histamine2-receptor antagonists (H2RAs) for 2 weeks, and if still asymptomatic, H2RAs were discontinued. If symptoms recurred, H2RAs were reinitiated, and if still symptomatic, subjects were prescribed PPIs at the dose that initially alleviated their symptoms. Intermittent therapy: Intermittent therapy subjects discontinued daily use of PPIs and were prescribed short courses of PPI (daily for 8 weeks) for recurrence of GERD symptoms. The primary efficacy measure was the proportion of subjects remaining free of GERD symptoms while on their prescribed therapy (step-down group: no symptoms on H2RAs or no GERD medication; intermittent therapy group: no PPIs for �2 weeks after discontinuation, and < 3 symptom recurrences requiring PPIs; control groups: no GERD symptoms on PPI). Follow up was conducted for 6 months after randomization. In addition to the primary efficacy measure, we examined total resource utilization (pharmacy and non-pharmacy), HRQOL, and potential predictors of non-response to step-down or intermittent therapy (requirement of daily PPI to control symptoms). Logistic regression and random-effects models adjusted for covariates and clustering effects.
Status:
Enrollment and follow-up have been completed. Efficacy measures are reported above. Outcome measures including comparison of direct health care costs, health-related quality of life, and determinants of non-response to step-down or intermittent therapy are being examined.
- Conditions
- Gastroesophageal Reflux Disease, Health Economics
- Being tested
- Disease management of gastroesophageal reflux disease
- Keywords
- Proton pump inhibitor
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease management of gastroesophageal reflux diseaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Disease management of gastroesophageal reflux disease |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- John Inadomi, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057174
- Sponsor's protocol ID
- IIR 99-238
- Status last verified
- Feb 2007
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Serag HB, Graham DY, Richardson P, Inadomi JM. Prevention of complicated ulcer disease among chronic users of nonsteroidal anti-inflammatory drugs: the use of a nomogram in cost-effectiveness analysis. Arch Intern Med. 2002 Oct 14;162(18):2105-10. doi: 10.1001/archinte.162.18.2105.
PubMed 12374519Rubenstein JH, Inadomi JM. Empiric beta-blockers for the prophylaxis of variceal hemorrhage: cost effective or clinically applicable? Hepatology. 2003 Feb;37(2):249-52. doi: 10.1053/jhep.2003.50089. No abstract available.
PubMed 12540773Rubenstein JH, Inadomi JM. Dysphagia drives doctors to diagnose a disease: pitfalls in interpreting observational studies. Gastrointest Endosc. 2005 Jun;61(7):809-11. doi: 10.1016/s0016-5107(05)00544-4. No abstract available.
PubMed 15933680Rubenstein JH, Vakil N, Inadomi JM. The cost-effectiveness of biomarkers for predicting the development of oesophageal adenocarcinoma. Aliment Pharmacol Ther. 2005 Jul 15;22(2):135-46. doi: 10.1111/j.1365-2036.2005.02536.x.
PubMed 16011672Rubenstein JH, Davis J, Marrero JA, Inadomi JM. Relationship between diabetes mellitus and adenocarcinoma of the oesophagus and gastric cardia. Aliment Pharmacol Ther. 2005 Aug 1;22(3):267-71. doi: 10.1111/j.1365-2036.2005.02544.x.
PubMed 16091065Rhee J, Scheiman J, Inadomi J. "Spontaneous" passage of a pancreatic duct stone. Gastrointest Endosc. 2003 Feb;57(2):278-80. doi: 10.1067/mge.2003.62. No abstract available.
PubMed 12556808Chey WD, Inadomi JM, Booher AM, Sharma VK, Fendrick AM, Howden CW. Primary-care physicians' perceptions and practices on the management of GERD: results of a national survey. Am J Gastroenterol. 2005 Jun;100(6):1237-42. doi: 10.1111/j.1572-0241.2005.41364.x.
PubMed 15929751Inadomi JM, Jamal R, Murata GH, Hoffman RM, Lavezo LA, Vigil JM, Swanson KM, Sonnenberg A. Step-down management of gastroesophageal reflux disease. Gastroenterology. 2001 Nov;121(5):1095-100. doi: 10.1053/gast.2001.28649.
PubMed 11677201Inadomi JM, McIntyre L, Bernard L, Fendrick AM. Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs. Am J Gastroenterol. 2003 Sep;98(9):1940-4. doi: 10.1111/j.1572-0241.2003.07665.x.
PubMed 14499769Inadomi JM. Update on the cost-effectiveness of screening for colorectal neoplasia. Curr Opin Gastroenterol. 2003 Jan;19(1):44-50. doi: 10.1097/00001574-200301000-00008.
PubMed 15699893Inadomi JM. On-demand and intermittent therapy for gastro-oesophageal reflux disease: economic considerations. Pharmacoeconomics. 2002;20(9):565-76. doi: 10.2165/00019053-200220090-00001.
PubMed 12141885Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. doi: 10.7326/0003-4819-138-3-200302040-00009.
PubMed 12558356Inadomi JM. Cost-effectiveness of colorectal cancer surveillance in ulcerative colitis. Scand J Gastroenterol Suppl. 2003;(237):17-21. doi: 10.1080/00855910310001430.
PubMed 12797675Inadomi JM, Fendrick AM. PPI use in the OTC era: who to treat, with what, and for how long? Clin Gastroenterol Hepatol. 2005 Mar;3(3):208-15. doi: 10.1016/s1542-3565(04)00717-7.
PubMed 15765438Inadomi J, Fendrick AM. Dyspepsia: Physicians Information and Education Resource. PIER. 2003 Jan 1.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Impact of Guidelines for Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00057174
- Acronym / sponsor ID
- IIR 99-238
- Conditions
- Gastroesophageal Reflux Disease, Health Economics
- Keywords
- Proton pump inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Oregon Health and Science University
- Study completion
- Jun 2004 (actual)
- First posted
- 28 Mar 2003 (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.
This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.
Detailed description
Background:
This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.
Objectives:
The objectives of this project are to determine the efficacy of step-down therapy and intermittent therapy in patients with GERD, and the impact of these strategies on direct healthcare costs and health-related quality of life (HRQOL). Additionally, we will examine patient factors predictive of non-response to these management strategies that may be alternatives to traditional continuous PPI administration.
Methods:
Two separate studies were conducted in our population of patients with GERD symptoms (heartburn or acid regurgitation) rendered asymptomatic on PPIs. Both studies randomized subjects to an intervention strategy (Step-down or Intermittent therapy) or to a control group in which PPIs were continued on a daily basis.
Step-down therapy: Step-down subjects discontinued PPIs and were prescribed histamine2-receptor antagonists (H2RAs) for 2 weeks, and if still asymptomatic, H2RAs were discontinued. If symptoms recurred, H2RAs were reinitiated, and if still symptomatic, subjects were prescribed PPIs at the dose that initially alleviated their symptoms. Intermittent therapy: Intermittent therapy subjects discontinued daily use of PPIs and were prescribed short courses of PPI (daily for 8 weeks) for recurrence of GERD symptoms. The primary efficacy measure was the proportion of subjects remaining free of GERD symptoms while on their prescribed therapy (step-down group: no symptoms on H2RAs or no GERD medication; intermittent therapy group: no PPIs for �2 weeks after discontinuation, and < 3 symptom recurrences requiring PPIs; control groups: no GERD symptoms on PPI). Follow up was conducted for 6 months after randomization. In addition to the primary efficacy measure, we examined total resource utilization (pharmacy and non-pharmacy), HRQOL, and potential predictors of non-response to step-down or intermittent therapy (requirement of daily PPI to control symptoms). Logistic regression and random-effects models adjusted for covariates and clustering effects.
Status:
Enrollment and follow-up have been completed. Efficacy measures are reported above. Outcome measures including comparison of direct health care costs, health-related quality of life, and determinants of non-response to step-down or intermittent therapy are being examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Disease management of gastroesophageal reflux disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with GERD symptoms treated with PPIs. For the purpose of this study, GERD symptoms include heartburn or acid regurgitation. Symptoms of dyspepsia (epigastric pain, nausea, bloating, early satiety) may be present, but may not be used as the sole criteria for inclusion into the study.
- Asymptomatic (no heartburn or acid regurgitation) on PPI therapy.
Key exclusion criteria (5 listed)
- Complications of gastroesophageal reflux disease including esophageal stricture, hemorrhage due to erosive esophagitis, Barrett�s esophagus or adenocarcinoma of the esophagus, or extra-esophageal manifestations of reflux disease (pulmonary or laryngeal disease due to acid reflux).
- Concurrent diagnoses of other gastrointestinal diseases including gastric or duodenal ulcer, Zollinger-Ellison syndrome or other hypersecretory disorders, or gastric cancer.
- Esophagitis secondary to non-acid peptic causes: infections (viral, bacterial, fungal), or medications causing esophageal erosions.
- Inability to maintain follow-up, either due to excessive distance to the VA primary care facility or lack of telephone services.
- Unwillingness to participate in the 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 |
|---|---|---|
| Disease management of gastroesophageal reflux disease | Drug | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 12374519El-Serag HB, Graham DY, Richardson P, Inadomi JM. Prevention of complicated ulcer disease among chronic users of nonsteroidal anti-inflammatory drugs: the use of a nomogram in cost-effectiveness analysis. Arch Intern Med. 2002 Oct 14;162(18):2105-10. doi: 10.1001/archinte.162.18.2105.
- Results publication: PubMed 12540773Rubenstein JH, Inadomi JM. Empiric beta-blockers for the prophylaxis of variceal hemorrhage: cost effective or clinically applicable? Hepatology. 2003 Feb;37(2):249-52. doi: 10.1053/jhep.2003.50089. No abstract available.
- Results publication: PubMed 15933680Rubenstein JH, Inadomi JM. Dysphagia drives doctors to diagnose a disease: pitfalls in interpreting observational studies. Gastrointest Endosc. 2005 Jun;61(7):809-11. doi: 10.1016/s0016-5107(05)00544-4. No abstract available.
- Results publication: PubMed 16011672Rubenstein JH, Vakil N, Inadomi JM. The cost-effectiveness of biomarkers for predicting the development of oesophageal adenocarcinoma. Aliment Pharmacol Ther. 2005 Jul 15;22(2):135-46. doi: 10.1111/j.1365-2036.2005.02536.x.
- Results publication: PubMed 16091065Rubenstein JH, Davis J, Marrero JA, Inadomi JM. Relationship between diabetes mellitus and adenocarcinoma of the oesophagus and gastric cardia. Aliment Pharmacol Ther. 2005 Aug 1;22(3):267-71. doi: 10.1111/j.1365-2036.2005.02544.x.
- Results publication: PubMed 12556808Rhee J, Scheiman J, Inadomi J. "Spontaneous" passage of a pancreatic duct stone. Gastrointest Endosc. 2003 Feb;57(2):278-80. doi: 10.1067/mge.2003.62. No abstract available.
- Results publication: PubMed 15929751Chey WD, Inadomi JM, Booher AM, Sharma VK, Fendrick AM, Howden CW. Primary-care physicians' perceptions and practices on the management of GERD: results of a national survey. Am J Gastroenterol. 2005 Jun;100(6):1237-42. doi: 10.1111/j.1572-0241.2005.41364.x.
- Results publication: PubMed 11677201Inadomi JM, Jamal R, Murata GH, Hoffman RM, Lavezo LA, Vigil JM, Swanson KM, Sonnenberg A. Step-down management of gastroesophageal reflux disease. Gastroenterology. 2001 Nov;121(5):1095-100. doi: 10.1053/gast.2001.28649.
- Results publication: PubMed 14499769Inadomi JM, McIntyre L, Bernard L, Fendrick AM. Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs. Am J Gastroenterol. 2003 Sep;98(9):1940-4. doi: 10.1111/j.1572-0241.2003.07665.x.
- Results publication: PubMed 15699893Inadomi JM. Update on the cost-effectiveness of screening for colorectal neoplasia. Curr Opin Gastroenterol. 2003 Jan;19(1):44-50. doi: 10.1097/00001574-200301000-00008.
- Results publication: PubMed 12141885Inadomi JM. On-demand and intermittent therapy for gastro-oesophageal reflux disease: economic considerations. Pharmacoeconomics. 2002;20(9):565-76. doi: 10.2165/00019053-200220090-00001.
- Results publication: PubMed 12558356Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. doi: 10.7326/0003-4819-138-3-200302040-00009.
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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.
John Inadomi, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease management of gastroesophageal reflux disease in people with Gastroesophageal Reflux Disease and Health Economics, run by US Department of Veterans Affairs 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 2 inclusion and 5 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 7 Apr 2015. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057174, which also lists 16 linked publications.
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 7 Apr 2015.