NCT00392080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

First QC Date

October 23, 2006

Last Update Submit

March 18, 2008

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (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

    7 days

Secondary Outcomes (11)

  • Incidence of treatment-emergent, all-causality GI body system adverse events

    Duration of trial

  • Severity of Dyspepsia Assessment (SODA)

    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.

    Duration of trial

  • Incidence of any gastric ulcer

    Duration of trial

  • Incidence of any duodenal ulcer

    Duration of trial

  • +6 more secondary outcomes

Study Arms (3)

3

PLACEBO COMPARATOR
Drug: placebo

1

EXPERIMENTAL

75 mg BID

Drug: naproxen

2

EXPERIMENTAL
Drug: CJ-023,423

Interventions

CJ-023,423DRUG

75 mg BID

2
placeboDRUG

placebo

3
naproxenDRUG

naproxen

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

San Diego, California, 92103-6204, United States

Location

Pfizer Investigational Site

Jupiter, Florida, 33458, United States

Location

Pfizer Investigational Site

Ocoee, Florida, 34761, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Pfizer Investigational Site

Houston, Texas, 77074, United States

Location

Pfizer Investigational Site

Houston, Texas, 77090, United States

Location

Pfizer Investigational Site

Chesapeake, Virginia, 23320, United States

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

grapiprantNaproxen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 25, 2006

Study Start

November 1, 2006

Study Completion

February 1, 2008

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

US(11)