Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs
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| ClinicalTrials.gov Identifier: NCT00443963 |
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Recruitment Status :
Terminated
(The Principal Investigator is no longer affiliated with the Study Site.)
First Posted : March 7, 2007
Last Update Posted : December 21, 2007
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyspepsia | Drug: Esomeprazole Magnesium | Phase 4 |
An extensive meta-analysis has confirmed that dyspeptic symptoms are common in individuals using non-steroidal anti-inflammatory drugs (NSAIDs) (1). Both esomeprazole 20 mg daily and esomeprazole 40 mg daily have been shown to be more effective than placebo for the control of upper gastrointestinal symptoms in patients receiving NSAIDs (2).
The mechanisms by which H, K-ATPase inhibitors protect against NSAID gastropathy remain unclear, although it is known that their use is more clinically effective than the use of the H2-receptor antagonist, ranitidine (3).
The biochemical basis for NSAID gastropathy is not fully understood (6). One potential mechanism for the development of gastric damage in individuals receiving NSAIDs is oxidative stress related to depletion of gastric antioxidants. A recent endoscopic study in patients supports the hypothesis that NSAID use associated with gastric bleeding decreases gastric mucosal glutathione levels (7), a major cellular micronutrient antioxidant produced by mammalian cells. We have been working on the possibility that activation of afferent nerve fibers by oxidative stress can induce abdominal discomfort during the use of NSAIDs. This notion is supported by animal studies that have shown that oxidants evoke neurotransmitter release from enteric neurons (8). This experimental result suggests that abnormal tissue levels of oxygen-derived free radicals (oxidative stress) could directly activate afferent enteric nerves or could alter gastric motility via a neuronal mechanism.
The hypothesis of this present proposal is that patients receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary aims of this study are to examine gastric free radical production and total antioxidant capacity in patients who are taking NSAID drugs and have dyspeptic symptoms. Gastric free radical production and total antioxidant capacity will be measured before and after receiving either 15 days of daily esomeprazole magnesium or ranitidine.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Esomeprazole Magnesium on Gastric Free Radical Production and Total Antioxidant Capacity in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs |
| Study Start Date : | December 2006 |
| Actual Study Completion Date : | December 2007 |
- gastric levels of total antioxidant capacity and gastric lipid peroxide levels on Day 22
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who are capable of providing informed consent, ages 18 years old and older. Patients will be eligible who are taking non-steroidal anti-inflammatory drugs on a daily basis and present with at least a 1 week history of dyspeptic symptoms including epigastric or upper abdominal discomfort or pain.
Exclusion Criteria:
- Patients presenting with only a complaint of heartburn will be excluded. Patients with alarm symptoms of vomiting, evidence of bleeding, inadvertent weight loss, or dysphagia will be excluded. Patients will be excluded if they have had upper endoscopy within 6 months prior to randomization. At the initial visit all individuals will have a Helicobacter pylori IgG serology drawn; all individuals with a positive serology will be excluded. This study will not enroll patients with a previous history of myocardial infarction, cerebrovascular infarction, gastric or duodenal ulcer disease, or carcinoma. The study will not enroll patients who have received a H, K-ATPase inhibitor within the past 2 weeks. At the initial upper endoscopy, all patients with esophageal ulcer, esophageal cancer, gastric ulcer, gastric cancer, and duodenal ulcer will be excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443963
| United States, District of Columbia | |
| Washington Hospital Center | |
| 110 Irving St. NW, Washington, District of Columbia, United States, 20010 | |
| Principal Investigator: | Timothy R Koch, MD | Washington Hospital Center |
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00443963 History of Changes |
| Other Study ID Numbers: |
IRUSESOM0391 |
| First Posted: | March 7, 2007 Key Record Dates |
| Last Update Posted: | December 21, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Medstar Health Research Institute:
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Dyspepsia in patients taking NSAIDs |
Additional relevant MeSH terms:
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Dyspepsia Signs and Symptoms, Digestive Signs and Symptoms Esomeprazole Anti-Inflammatory Agents Antioxidants Anti-Inflammatory Agents, Non-Steroidal Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents |