Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs

NCT00443963 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRUSESOM0391
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).

Conditions

Dyspepsia

Keywords

Dyspepsia in patients taking NSAIDs

Outcome Measures

Primary Outcomes (1)

• gastric levels of total antioxidant capacity and gastric lipid peroxide levels on Day 22

  Measurement of tissue levels in stomach biopsies of total antioxidant capacity (in nmole of Trolox equivalent/g wet tissue) and lipid peroxides (in nmole/g wet tissue).

  1 week

Study Arms (2)

PPI

EXPERIMENTAL

PPI Medication

Drug: Esomeprazole Magnesium

H2RA

EXPERIMENTAL

H2RA Medication

Drug: Esomeprazole Magnesium

Interventions

Esomeprazole Magnesium DRUG

PPI compared to H2RA

Also known as: Ranitidine

H2RA; PPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are capable of providing informed consent, ages 18 years old and older. Partipants who are taking non-steroidal anti-inflammatory drugs on a daily basis must present with at least a 1 week history of dyspeptic symptoms including epigastric or upper abdominal discomfort or pain.

You may not qualify if:

• Participants presenting with only a complaint of heartburn will be excluded. Participants with alarm symptoms of vomiting, evidence of bleeding, inadvertent weight loss, or dysphagia will be excluded. Participants will be excluded if they have had upper endoscopy within 6 months prior to randomization. At the initial visit, participants will have a Helicobacter pylori IgG serology drawn and all participants with a positive serology will be excluded. Participants with a previous history of myocardial infarction, cerebrovascular infarction, gastric or duodenal ulcer disease, or carcinoma will be excluded. The study will not enroll participants who have received a H, K-ATPase inhibitor within the past 2 weeks. At the initial upper endoscopy, all participants with esophageal ulcer, esophageal cancer, gastric ulcer, gastric cancer, and duodenal ulcer will be excluded.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• AstraZeneca: collaborator

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (5)

• Ofman JJ, Maclean CH, Straus WL, Morton SC, Berger ML, Roth EA, Shekelle PG. Meta-analysis of dyspepsia and nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2003 Aug 15;49(4):508-18. doi: 10.1002/art.11192.

  PMID: 12910557 BACKGROUND

• Hawkey C, Talley NJ, Yeomans ND, Jones R, Sung JJ, Langstrom G, Naesdal J, Scheiman JM; NASA1 SPACE1 Study Group. Improvements with esomeprazole in patients with upper gastrointestinal symptoms taking non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors. Am J Gastroenterol. 2005 May;100(5):1028-36. doi: 10.1111/j.1572-0241.2005.41465.x.

  PMID: 15842575 BACKGROUND

• Yeomans ND, Tulassay Z, Juhasz L, Racz I, Howard JM, van Rensburg CJ, Swannell AJ, Hawkey CJ. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med. 1998 Mar 12;338(11):719-26. doi: 10.1056/NEJM199803123381104.

  PMID: 9494148 BACKGROUND

• Koch TR, Petro A, Darrabie M, Opara EC. Effect of the H, K-ATPase inhibitor, esomeprazole magnesium, on gut total antioxidant capacity in mice. J Nutr Biochem. 2004 Sep;15(9):522-6. doi: 10.1016/j.jnutbio.2004.03.003.

  PMID: 15350983 BACKGROUND

• Koch TR, Petro A, Darrabie M, Opara EC. Effects of esomeprazole magnesium on nonsteroidal anti-inflammatory drug gastropathy. Dig Dis Sci. 2005 Jan;50(1):86-93. doi: 10.1007/s10620-005-1283-z.

  PMID: 15712643 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dyspepsia

Interventions

Esomeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Study Officials

• Timothy R Koch, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

US (1)