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CG5503 IR; tapentadol

Phase 3

Arthralgia | Small molecule | Musculoskeletal |Johnson & Johnson|Last Updated: Jun 9, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment602

FDA Designations

No designations recorded

Clinical trial landscape

CG5503 IR; tapentadol · 1 trial · 5 indications

Phase 3 1
NCT00364247A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.Arthralgia
COMPLETED602 Analytics
PHASE3COMPLETED
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.
Arthralgia
NCT00364247602
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Study Endpoints

Primary Endpoints

The primary effectiveness outcome for this study is SPID48 (i.e., the sum of pain intensity difference at 48 hours relative to the first dose).

Secondary Endpoints

Secondary effectiveness outcomes include, among others, the effect of CG5503 IR on the time to the need for the first rescue pain medication during the double-blind treatment period, and the SPID at 12, 24, and 72 hours relative to first dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CG5503 IR;tapentadolDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must undergo primary unilateral first metatarsal bunionectomy * pain intensity must be moderate to severe following stoppage of a continuous popliteal sciatic block (a nerve block with local anesthetic that numbs the foot) * female patients must be postmenopausal, sur...

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Frequently asked questions about CG5503 IR; tapentadol

What is CG5503 IR (tapentadol) used for?

CG5503 IR (tapentadol) is an investigational small molecule being studied for the treatment of arthralgia and osteoarthritis. It is being evaluated in patients awaiting joint replacement surgery and in the treatment of acute pain from bunionectomy. The drug is in Phase 3 clinical development.

Who makes CG5503 IR (tapentadol)?

CG5503 IR (tapentadol) is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting Phase 3 clinical trials to evaluate the drug's effectiveness and safety in patients with osteoarthritis and arthralgia.

What phase is CG5503 IR (tapentadol) in?

CG5503 IR (tapentadol) is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, one in patients awaiting joint replacement surgery and another in patients with acute pain from bunionectomy.

What clinical trials is CG5503 IR (tapentadol) in?

CG5503 IR (tapentadol) has completed two Phase 3 clinical trials. NCT00361582 evaluated multiple doses in 669 patients awaiting joint replacement surgery for osteoarthritis. NCT00364247 evaluated the drug in 602 patients with acute pain from bunionectomy compared with placebo, followed by an open-label extension.

Is CG5503 IR (tapentadol) the same as tapentadol?

Yes, CG5503 IR is the same drug as tapentadol. The name CG5503 IR refers to the immediate-release formulation of tapentadol, which is being studied in Phase 3 clinical trials for the treatment of arthralgia and osteoarthritis.