Official Title: “A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects”

CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: CJ-023,423
  • 75 mg BID
• Drug: placebo
  • placebo
• Drug: naproxen
  • naproxen

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 3
• Experimental: 1
  • 75 mg BID
• Experimental: 2

Primary Measures

• The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
  • Time Frame: 7 days
    Safety Issue?: No

Secondary Measures

• Incidence of treatment-emergent, all-causality GI body system adverse events
  • Time Frame: Duration of trial
    Safety Issue?: No
• Severity of Dyspepsia Assessment (SODA)
  • Time Frame: Duration of trial
    Safety Issue?: No
• Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any gastric ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any duodenal ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any gastroduodenal erosion or ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any gastric erosion or ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any duodenal erosion or ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer
  • Time Frame: Duration of trial
    Safety Issue?: No
• Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)
  • Time Frame: Duration of trial
    Safety Issue?: No
• Number of gastroduodenal ulcers in each subject
  • Time Frame: Duration of trial
    Safety Issue?: No

Inclusion Criteria:

• Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
• If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;

Exclusion Criteria:

• Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
• Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00392080

Study ID Number: A5231018

ClinicalTrials.gov Identifier: NCT00392080

Health Authority: United States: Food and Drug Administration

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