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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: placebo; Drug: CJ-023,423; Drug: naproxen

• Registration Number: NCT00392080
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-25
• Study Start: 2006-11
• Study Completion: 2008-02
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-18
• Last Update Posted: 2008-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	-
2	CJ-023,423	-
1	naproxen	75 mg BID

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Chesapeake, Virginia, United States