NCT00778193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

July 24, 2008

Last Update Submit

October 22, 2008

Conditions

Gastroduodenal Ulcer

Keywords

NSAIDulcergastroduodenal ulcernaproxenaspirinASAcelecoxibclopidogrelhealingCyclooxygenase 2 InhibitorsAnti-Inflammatory Agents, Non-SteroidalPlatelet Aggregation InhibitorsWound Healing

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Naproxen

ACTIVE COMPARATOR
Drug: Naproxen

Aspirin

EXPERIMENTAL
Drug: Aspirin

Clopidogrel

EXPERIMENTAL
Drug: Clopidogrel

Celecoxib

EXPERIMENTAL
Drug: Celecoxib

Interventions

NaproxenDRUG

1 tablet 500mg BID for 8 days

Also known as: naprosyn, naproxen sodium, Aleve, Anaprox, Miranax, Naprogesic, Naprelan, Proxen, Synflex
Naproxen
AspirinDRUG

1 tablet 81mg QD for 8 days

Also known as: ASA, Bayer
Aspirin
CelecoxibDRUG

1 capsule 200mg QD for 8 days

Also known as: Celebrex
Celecoxib
ClopidogrelDRUG

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

Also known as: Plavix
Clopidogrel
PlaceboDRUG

1 capsule BID for 8 days

Also known as: sugar pill
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age 18-75
  • Use of appropriate form of birth control for women of childbearing potential.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Associates of New York

New York, New York, 10075, United States

Location

Related Publications (1)

  • 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.

    PMID: 18224442BACKGROUND

MeSH Terms

Conditions

Peptic UlcerUlcer

Interventions

NaproxenAspirinCelecoxibClopidogrelSugars

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesBenzenesulfonamidesSulfonamidesAmidesSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesThiophenesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarbohydrates

Study Officials

  • James Aisenberg, MD

    Research Associates of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2008

First Posted

October 23, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations

US(1)