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
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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 |

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 |
- 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 ]
- Incidence of treatment-emergent, all-causality GI body system adverse events [ Time Frame: Duration of trial ]
- Severity of Dyspepsia Assessment (SODA) [ Time Frame: 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. [ Time Frame: Duration of trial ]
- Incidence of any gastric ulcer [ Time Frame: Duration of trial ]
- Incidence of any duodenal ulcer [ Time Frame: Duration of trial ]
- Incidence of any gastroduodenal erosion or ulcer [ Time Frame: Duration of trial ]
- Incidence of any gastric erosion or ulcer [ Time Frame: Duration of trial ]
- Incidence of any duodenal erosion or ulcer [ Time Frame: Duration of trial ]
- Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer [ Time Frame: 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) [ Time Frame: Duration of trial ]
- 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 |
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;

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
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 |
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 |