NCT00057174

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 27, 2003

Last Update Submit

April 6, 2015

Conditions

Gastroesophageal Reflux DiseaseHealth Economics

Keywords

Proton pump inhibitor

Study Arms (1)

Arm 1

OTHER
Drug: Disease management of gastroesophageal reflux disease

Interventions

Disease management of gastroesophageal reflux diseaseDRUG
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic (no heartburn or acid regurgitation) on PPI therapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (16)

  • 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.

    PMID: 12374519RESULT

  • Rubenstein 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.

    PMID: 12540773RESULT

  • Rubenstein 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.

    PMID: 15933680RESULT

  • Rubenstein 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.

    PMID: 16011672RESULT

  • Rubenstein 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.

    PMID: 16091065RESULT

  • Rhee 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.

    PMID: 12556808RESULT

  • Chey 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.

    PMID: 15929751RESULT

  • Inadomi 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.

    PMID: 11677201RESULT

  • Inadomi 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.

    PMID: 14499769RESULT

  • Inadomi 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.

    PMID: 15699893RESULT

  • Inadomi 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.

    PMID: 12141885RESULT

  • Inadomi 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.

    PMID: 12558356RESULT

  • Inadomi JM. Cost-effectiveness of colorectal cancer surveillance in ulcerative colitis. Scand J Gastroenterol Suppl. 2003;(237):17-21. doi: 10.1080/00855910310001430.

    PMID: 12797675RESULT

  • Inadomi 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.

    PMID: 15765438RESULT

  • Inadomi J, Fendrick AM. Dyspepsia: Physicians Information and Education Resource. PIER. 2003 Jan 1.

    RESULT

  • Cram P, Fendrick AM, Inadomi J, Cowen ME, Carpenter D, Vijan S. The impact of a celebrity promotional campaign on the use of colon cancer screening: the Katie Couric effect. Arch Intern Med. 2003 Jul 14;163(13):1601-5. doi: 10.1001/archinte.163.13.1601.

    PMID: 12860585RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • John Inadomi, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2003

First Posted

March 28, 2003

Study Completion

June 1, 2004

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)