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CJ-023, 423

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Mar 24, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment340

FDA Designations

No designations recorded

Clinical trial landscape

CJ-023, 423 · 1 trial · 1 indication

Phase 1 1
NCT00392080A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach UlcersOsteoarthritis
COMPLETED340 Analytics
PHASE1COMPLETED
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
3PLACEBO_COMPARATOR -
1EXPERIMENTAL75 mg BID
2EXPERIMENTAL -

Interventions

NameTypeDescription
CJ-023,423DRUG75 mg BID
placeboDRUGplacebo
naproxenDRUGnaproxen
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites11

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\...

Countries:United States
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Frequently asked questions about CJ-023, 423

What is CJ-023,423 used for?

CJ-023,423 is an investigational small molecule being studied for osteoarthritis. It is being developed by Pfizer, Inc. (PFE). The drug is currently in Phase 1 clinical development and is not approved by the FDA.

What does CJ-023,423 target?

The molecular target of CJ-023,423 has not been disclosed in available information. The drug is a small molecule being evaluated for its effect on the incidence of stomach ulcers in patients with osteoarthritis.

Who makes CJ-023,423?

CJ-023,423 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is CJ-023,423 in?

CJ-023,423 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is CJ-023,423 in?

CJ-023,423 has one completed Phase 1 trial, NCT00392080, titled "A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers." The trial enrolled 340 participants with osteoarthritis in the United States and was placebo-controlled, randomized, and double-blind.

Is CJ-023,423 the same as any other drug?

No alternative names for CJ-023,423 have been reported. The drug is identified solely by its code name CJ-023,423 in clinical trial records.