Rabeprazole Protection of Aspirin Induced Gastric Damage.

NCT00220857 | Completed Phase 4

• 1 other identifier: TU4504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of rabeprazole in preventing or decreasing acute gastroduodenal injury caused by therapeutic doses of aspirin in a placebo-controlled, randomized, double-blind parallel group study.

Conditions

Normal Subjects

Keywords

Rabeprazole; Nonsteroidal Antiinflammatory Drugs; Gastric erosions

Outcome Measures

Primary Outcomes (1)

• Gastric mucosal abnormalities

Secondary Outcomes (1)

• Hemoglobin

Interventions

Rabeprazole DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A normal subject must be between 18 and 60 years of age with no history of gastrointestinal disease, gastroduodenal surgery, upper gastrointestinal symptoms or cardiopulmonary disease of any kind.

You may not qualify if:

• Normal subjects should have not ingested a salicylate, nonsteroidal antiinflammatory drug, histamine-2 receptor antagonist, proton pump inhibitor, misoprostol or carafate within one month of entering this study.
• He/she should not have participated in an investigational study within 3 months of this protocol.
• Pregnant women and women not using an accepted method of birth control will be excluded.
• Patients will be excluded who are allergic to aspirin and NSAIDs, who have an intolerance to aspirin and NSAIDs, who have a history of asthma and/or nasal polyps.
• Patients will be excluded if they have a history of gastric ulcers, duodenal ulcers, gastrointestinal bleeding, or bleeding disorder, clotting disorder.
• Patients will be excluded who actively abuse alcohol, as defined by greater than three twelve ounce beers or greater than three drinks containing hard liquor per day.
• Patients with a history of intracranial bleeding and/or brain trauma will be excluded from this research.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert S Fisher, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

US (1)