A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach

• ClinicalTrials.gov Identifier: NCT00261586
• Recruitment Status: Completed
• First Posted: December 5, 2005
• Last Update Posted: June 29, 2011
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by: Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information

• First Submitted Date: December 2, 2005
• First Posted Date: December 5, 2005
• Last Update Posted Date: June 29, 2011
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: December 2, 2005): Percent arachidonic acid-induced platelet aggregation; Lanza Mucosal Injury Score of the stomach
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 2, 2005): Serum thromboxane B2; plasma PGE2; shear-induced platlet aggregation; cyclooxygenase activity in stomach mucosal biopsies as assessed by PGE2 content
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach
• Official Title: Effect of Analgesics on the Irreversible Inactivation of Cyclooxygenase-1 Activity by Low Dose Aspirin and Endoscopic Evaluation of the Gastric Mucosal Effect
• Brief Summary: The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.
• Detailed Description: The purpose of this randomized, multiple-dose, single-blind, parallel-group study is to examine in healthy volunteers the effects of analgesics given in approved daily doses in addition to daily cardio-protective doses of aspirin (81 mg) on the stomach. All subjects are examined endoscopically before receiving study medication, and at the end of treatment on Day 9. Each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken daily on Days 1 through 8: four doses of acetaminophen 1000 mg, three doses of ibuprofen 400 mg, two doses of naproxen sodium (440 mg in the morning and 220 mg in the evening), four doses of aspirin 650 mg, two doses of celecoxib 200 mg, one dose of rofecoxib 25 mg, or no additional study medication. On Day 9, one dose of aspirin 81 mg and only one dose of the assigned treatment drug are taken prior to having an endoscopy. The primary endpoints of the study are the effects of the analgesics on the inhibition of COX-1 activity by aspirin, and any injury to the stomach mucosa, as determined by direct endoscopic observation. Safety assessments consist of routine monitoring for adverse events, as well as endoscopic examination of gastric mucosa for erosions and ulcerations occurring during the treatment phase. The study hypothesis is that the effects of acetaminophen on the stomach do not differ from the effects of ibuprofen, naproxen, aspirin, celecoxib, or rofecoxib. 81 mg aspirin and 1of 7 treatments for 8 days: acetaminophen 1000mg 4xday, ibuprofen 400mg 3xday, naproxen 440mg morning and 220mg evening, no additional study medication, aspirin 650mg 4xday, celecoxib 200mg 2xday,rofecoxib 25mg 1xday. On Day 9, 1 dose aspirin & 1 dose study drug before endoscopy.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment
• Condition: Analgesics
• Intervention: Drug: aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2009): 92
• Original Enrollment (submitted: December 2, 2005): 84
• Actual Study Completion Date: March 2004
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• In general good health with normal hemostatic (blood coagulation) parameters
• able to swallow study medication
• non-smoker
• negative for H. pylori infection
• if female, must not be pregnant or breast feeding

Exclusion Criteria:

• Have taken anti-inflammatory drugs within one week of study entry, any analgesic within 24 hours before baseline endoscopy, or systemic steroids within 6 weeks of study entry
• unable to tolerate oral drugs or have had gastrointestinal disease or prior gastrointestinal surgery that could interfere with the study medication
• unable to understand or follow instructions
• have a medical condition or clinically significant abnormal laboratory results that may be relevant to participation in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00261586
• Other Study ID Numbers: CR002500
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Original Study Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial; McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

• PRS Account: Johnson & Johnson Consumer and Personal Products Worldwide
• Verification Date: June 2011