Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs
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ClinicalTrials.gov Identifier: NCT00443963 |
Recruitment Status :
Withdrawn
(The study was not approved by the Human Studies Subcommittee.)
First Posted : March 7, 2007
Last Update Posted : August 24, 2020
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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. The principal investigator has 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 participants 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 participants 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) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
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 |
Estimated Study Start Date : | December 2006 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: PPI
PPI Medication
|
Drug: Esomeprazole Magnesium
PPI compared to H2RA
Other Name: Ranitidine |
Experimental: H2RA
H2RA Medication
|
Drug: Esomeprazole Magnesium
PPI compared to H2RA
Other Name: Ranitidine |
- gastric levels of total antioxidant capacity and gastric lipid peroxide levels on Day 22 [ Time Frame: 1 week ]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).

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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:
- 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.
Exclusion Criteria:
- 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.

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 | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Timothy R Koch, MD | Medstar Health Research Institute |
Publications:
Responsible Party: | Timothy Koch, Principal Investigator, Medstar Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00443963 |
Other Study ID Numbers: |
IRUSESOM0391 |
First Posted: | March 7, 2007 Key Record Dates |
Last Update Posted: | August 24, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Dyspepsia in patients taking NSAIDs |
Dyspepsia Signs and Symptoms, Digestive Esomeprazole Ranitidine Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs |