Abstract

This protocol is a phase III, double-blind, randomized, baseline-controlled, two-treatment crossover study to separately evaluate the effects of pantoprazole 40 mg and omeprazole 20 mg on intragastric and intraesophageal pH profiles in patients with gastroesophageal reflux disease (GERD). Patients undergo a screening endoscopy, manometry and pH measurement. Eligible patients receive one of two study drugs for 8 days separated by at least a 10-day washout period before receiving the other study medication. In addition to a 24-hour overnight stay for baseline pH measurement, each treatment period requires two overnight stays for 24-hour dual intragastric and intraesophageal pH measurement. Each patient will participate in the study for approximately 6.5 (up to 8) weeks. With this study, therefore, the investigator will measure the extent of suppression of gastric acid secretion on day 1 (onset) and day 8 of treatment for each medication. Information about GERD symptomatology will also be collected.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000030-39
Application #
6408278
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1975-10-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Duke University
Department
Type
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705

  Publications

Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32
Paine, Nicola J; Watkins, Lana L; Blumenthal, James A et al. (2015) Association of depressive and anxiety symptoms with 24-hour urinary catecholamines in individuals with untreated high blood pressure. Psychosom Med 77:136-44

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