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Trial record 1 of 2 for:    CJ-023,423
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A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

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ClinicalTrials.gov Identifier: NCT00392080
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: CJ-023,423 Drug: placebo Drug: naproxen Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2006
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Naproxen

Arm Intervention/treatment
Placebo Comparator: 3 Drug: placebo
placebo

Experimental: 1
75 mg BID
Drug: naproxen
naproxen

Experimental: 2 Drug: CJ-023,423
75 mg BID




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent, all-causality GI body system adverse events [ Time Frame: Duration of trial ]
  2. Severity of Dyspepsia Assessment (SODA) [ Time Frame: Duration of trial ]
  3. 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 ]
  4. Incidence of any gastric ulcer [ Time Frame: Duration of trial ]
  5. Incidence of any duodenal ulcer [ Time Frame: Duration of trial ]
  6. Incidence of any gastroduodenal erosion or ulcer [ Time Frame: Duration of trial ]
  7. Incidence of any gastric erosion or ulcer [ Time Frame: Duration of trial ]
  8. Incidence of any duodenal erosion or ulcer [ Time Frame: Duration of trial ]
  9. Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer [ Time Frame: Duration of trial ]
  10. 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 ]
  11. Number of gastroduodenal ulcers in each subject [ Time Frame: Duration of trial ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Ocoee, Florida, United States, 34761
Pfizer Investigational Site
South Miami, Florida, United States, 33143
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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00392080     History of Changes
Other Study ID Numbers: A5231018
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action