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

NCT ID: NCT00392080

Last Updated: 2008-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

1

75 mg BID

Group Type EXPERIMENTAL

naproxen

Intervention Type DRUG

naproxen

2

Group Type EXPERIMENTAL

CJ-023,423

Intervention Type DRUG

75 mg BID

Interventions

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CJ-023,423

75 mg BID

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

naproxen

naproxen

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Anaheim, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Jupiter, Florida, United States

Site Status

Pfizer Investigational Site

Ocoee, Florida, United States

Site Status

Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Chesapeake, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5231018&StudyName=A%20Study%20Of%20The%20Effect%20Of%20CJ-023%2C423%20On%20The%20Incidence%20Of%20Stomach%20Ulcers

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

Other Identifiers

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A5231018

Identifier Type: -

Identifier Source: org_study_id