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Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers (Lesions2)

Primary Purpose

Gastroduodenal Ulcer

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Naproxen

Aspirin

Celecoxib

Clopidogrel

Placebo

About this trial

This is an interventional trial for Gastroduodenal Ulcer focused on measuring NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel, healing, Cyclooxygenase 2 Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Platelet Aggregation Inhibitors, Wound Healing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Associates of New York

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Naproxen

Aspirin

Clopidogrel

Celecoxib

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00778193

First Posted

July 24, 2008

Last Updated

October 22, 2008

Sponsor

Research Associates of New York, LLP

1. Study Identification

Unique Protocol Identification Number

NCT00778193

Brief Title

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

Acronym

Lesions2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Research Associates of New York, LLP

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroduodenal Ulcer

Keywords

NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel, healing, Cyclooxygenase 2 Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Platelet Aggregation Inhibitors, Wound Healing

7. Study Design

Study Phase

Phase 4

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Naproxen

Arm Type

Active Comparator

Arm Title

Aspirin

Arm Type

Experimental

Arm Title

Clopidogrel

Arm Type

Experimental

Arm Title

Celecoxib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Naproxen

Other Intervention Name(s)

naprosyn, naproxen sodium, Aleve, Anaprox, Miranax, Naprogesic, Naprelan, Proxen, Synflex

Intervention Description

1 tablet 500mg BID for 8 days

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

ASA, Bayer

Intervention Description

1 tablet 81mg QD for 8 days

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

Celebrex

Intervention Description

1 capsule 200mg QD for 8 days

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

sugar pill

Intervention Description

1 capsule BID for 8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Aisenberg, MD

Organizational Affiliation

Research Associates of New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Associates of New York

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18224442

Citation

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.

Results Reference

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

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