A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00392080
First received: October 23, 2006
Last updated: March 18, 2008
Last verified: March 2008
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
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 |
|---|---|
| Placebo Comparator: 3 |
Drug: placebo
placebo
|
|
Experimental: 1
75 mg BID
|
Drug: naproxen
naproxen
|
| Experimental: 2 |
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 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00392080 History of Changes |
| Other Study ID Numbers: | A5231018 |
| Study First Received: | October 23, 2006 |
| Last Updated: | March 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013