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Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers

Information source: Research Associates of New York, LLP
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroduodenal Ulcer

Intervention: Naproxen (Drug); Aspirin (Drug); Celecoxib (Drug); Clopidogrel (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Research Associates of New York, LLP

Official(s) and/or principal investigator(s):
James Aisenberg, MD, Principal Investigator, Affiliation: Research Associates of New York

Summary

Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.

Clinical Details

Official title: A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing

Study design: N/A

Detailed description: In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated. After all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent

- Age 18-75

- Use of appropriate form of birth control for women of childbearing potential.

Exclusion Criteria:

- H pylori infection

- Use of NSAIDs within 2 weeks prior to start of enrollment

- Use of antacids or H-2 blockers within 2 weeks of enrollment

- Use of PPIs within 30 days of enrollment

- Corticosteroid use within 60 days of enrollment

- History of a previous ulcer

- Diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment

- Use of cigarettes within 6 months of enrollment

- Consumption of >3 alcoholic beverages per day

- Hypersensitivity or allergy to NSAIDs, clopidogrel, or corn starch, or any

contraindications to ingesting those substances

- The presence of an ulcer at a baseline endoscopy

- Endoscopically severe gastritis or duodenitis baseline endoscopy

- Moderate or severe inflammation located within the duodenal bulb or within 2cm of the

pyloric channel at a baseline endoscopy

- Any gastroduodenal tumor.

Locations and Contacts

Research Associates of New York, New York, New York 10075, United States
Additional Information

Related publications:

Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.

Starting date: October 2007
Last updated: October 22, 2008

Page last updated: August 23, 2015

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