Clinical trial NCT00392080: A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;

Primary outcomes:
measure: The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of treatment-emergent, all-causality GI body system adverse events
timeFrame: Duration of trial
measure: Severity of Dyspepsia Assessment (SODA)
timeFrame: Duration of trial
measure: 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.
timeFrame: Duration of trial
measure: Incidence of any gastric ulcer
timeFrame: Duration of trial
measure: Incidence of any duodenal ulcer
timeFrame: Duration of trial
measure: Incidence of any gastroduodenal erosion or ulcer
timeFrame: Duration of trial
measure: Incidence of any gastric erosion or ulcer
timeFrame: Duration of trial
measure: Incidence of any duodenal erosion or ulcer
timeFrame: Duration of trial
measure: Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer
timeFrame: Duration of trial
measure: Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)
timeFrame: Duration of trial
measure: Number of gastroduodenal ulcers in each subject
timeFrame: Duration of trial
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocoee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Chesapeake
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: