A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

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 Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: placebo; Drug: naproxen; Drug: CJ-023,423

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103-6204
      • Pfizer Investigational Site
  • Florida
    • Jupiter, Florida, United States, 33458
      • Pfizer Investigational Site
    • Ocoee, Florida, United States, 34761
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10021
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27607
      • Pfizer Investigational Site
  • Texas
    • Houston, Texas, United States, 77074
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77090
      • Pfizer Investigational Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2	Drug: CJ-023,423; 75 mg BID
PLACEBO_COMPARATOR: 3	Drug: placebo; placebo
EXPERIMENTAL: 1; 75 mg BID	Drug: naproxen; naproxen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent, all-causality GI body system adverse events	Duration of trial
Severity of Dyspepsia Assessment (SODA)	Duration of trial
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.	Duration of trial
Incidence of any gastric ulcer	Duration of trial
Incidence of any duodenal ulcer	Duration of trial
Incidence of any gastroduodenal erosion or ulcer	Duration of trial
Incidence of any gastric erosion or ulcer	Duration of trial
Incidence of any duodenal erosion or ulcer	Duration of trial
Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer	Duration of trial
Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)	Duration of trial
Number of gastroduodenal ulcers in each subject	Duration of trial

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: October 23, 2006
• First Submitted That Met QC Criteria: October 23, 2006
• First Posted (ESTIMATE): October 25, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): March 24, 2008
• Last Update Submitted That Met QC Criteria: March 18, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: A5231018