Rabeprazole Protection of Aspirin Induced Gastric Damage.

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00220857
First received: September 20, 2005
Last updated: January 2, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Normal Subjects
Drug: Rabeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Rapid Protection of the Gastroduodenal Mucosa Against Aspirin-Induced Damage by Rabeprazole

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Gastric mucosal abnormalities

Secondary Outcome Measures:
  • Hemoglobin

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Thirty (30) eligible normal subjects will be randomized to one of two study groups: rabeprazole 20 mg OD (n=15) or placebo OD (n=15). Both rabeprazole and identically appearing placebo will be given to Temple from Janssen Pharmaceuticals. The randomization schedule will be prepared by John Gaughan, PhD of Temple University School of Medicine Department of Biostatistics using a random number generator. The coded medications will be dispensed by Temple's Department of Pharmacy. Study subjects and the investigators will be blinded as to the subject receiving either placebo or rabeprazole. The sealed code will not be broken until after the data analysis.

Study subjects will be admitted to the Temple Clinical Research Center for the duration of the study. Appendix I has the study time line. Study subjects will arrive at the CRC at 6:00 A.M. on study day 1. Female subjects will have a urine pregnancy test performed. Blood tests will be obtained for salicylate and alcohol levels. Each study subject will receive a single dose of study drug (rabeprazole or placebo) at 7:00 A.M. on study days 1, 2 and 3—one hour before breakfast on days 1 and 3 and 90 minutes before breakfast on study day 2. All research subjects will receive aspirin (ASA), 325 mg tablets as 2 tablets with 8 oz. water every 4 hours at 8:30 A.M., 12:30 P.M., 4:30 P.M., 8:30 P.M., 12:30 A.M. and 4:30 A.M. daily for study days 1, 2 and 3 (a total of 3900 mg aspirin per day). Esophagogastroduodenoscopy will be performed at 8:00 A.M. on the mornings of days 2 and 4; that is, 24 hours and 72 hours after initiation of aspirin and test drug. During each endoscopy, the maximum number of submucosal hemorrhages and erosions in an endoscopic field from the anterior and posterior walls of the antrum will be counted. In addition, a Lanza score will be assigned for each endoscopic examination (Appendix II). Endoscopic photographs will be obtained for each endoscopic examination. A blood sample will be obtained at 7:00 A.M. on study days 2, 3 and 4 for measurement of hemoglobin and serum salicylate. Meals will be standardized as follows for each day of the study:

Breakfast: 8:00 A.M. (study days 1 and 3); 8:30 A.M. (study day 2) 2 eggs, 2 slices of soft white bread, 4 oz unsweetened orange juice Lunch: 1:00 P.M. (study days 1, 2 and 3) Turkey sandwich, 2 slices of wheat bread, lettuce, tomato, 1 orange, 8 oz apple juice Dinner: 6:00 P.M. (study days 1, 2 and 3) Two plain hamburgers, ketchup, mustard, lettuce and tomato; tossed green salad with thousand island dressing, 1 cup of French fries, 8 oz whole milk Snack: 10:00 P.M. (study days 1, 2 and 3) 4 graham crackers, 4 oz orange juice

If the Lanza score reaches 4 for any subject indicating widespread involvement of the stomach with submucosal hemorrhages, erosions, or ulcerations, that subject will not receive any more aspirin, but continue with study drug of placebo or rabeprazole. If this was detected on day 2 of the study, the subject will continue to receive the study drug with the repeat study endoscopy on day 4. If the Lanza score day 4 (the end of the study) is 4, the subject will be treated with rabeprazole 20 mg po qd for one month. If there was an ulcer, a repeat upper endoscopy will then be performed at 4 weeks to ensure healing.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Thirty (30) normal subjects will be recruited.

Inclusion criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220857

Locations
United States, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Robert S Fisher, MD Temple University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220857     History of Changes
Other Study ID Numbers: TU4504
Study First Received: September 20, 2005
Last Updated: January 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Temple University:
Rabeprazole
Nonsteroidal Antiinflammatory Drugs
Gastric erosions

Additional relevant MeSH terms:
Rabeprazole
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 22, 2014