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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00392080

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: CJ-023,423 Drug: placebo Drug: naproxen	Phase I

MedlinePlus related topics: Endoscopy Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of treatment-emergent, all-causality GI body system adverse events [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Severity of Dyspepsia Assessment (SODA) [ Time Frame: Duration of trial ] [ Designated as 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 ] [ Designated as safety issue: No ]
Incidence of any gastric ulcer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Incidence of any duodenal ulcer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Incidence of any gastroduodenal erosion or ulcer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Incidence of any gastric erosion or ulcer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Incidence of any duodenal erosion or ulcer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer [ Time Frame: Duration of trial ] [ Designated as 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 ] [ Designated as safety issue: No ]
Number of gastroduodenal ulcers in each subject [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	November 2006
Study Completion Date:	February 2008

Arms	Assigned Interventions
3: Placebo Comparator	Drug: placebo placebo
1: Experimental 75 mg BID	Drug: naproxen naproxen
2: Experimental	Drug: CJ-023,423 75 mg BID

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392080

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5231018
Study First Received:	October 23, 2006
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00392080
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Stomach Ulcer
Naproxen
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Ulcer
Healthy
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009