Recent Updates
Recently added Catalysts

CG 5503; tapentadol

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment877

FDA Designations

No designations recorded

Clinical trial landscape

CG 5503; tapentadol · 1 trial · 5 indications

Phase 3 1
NCT00364546A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic PainOsteoarthritis
COMPLETED877 Analytics
PHASE3COMPLETED
A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.

Secondary Endpoints

The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CG 5503;tapentadolDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months * require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates fo...

Unlock Eligibility Criteria

Frequently asked questions about CG 5503; tapentadol

What is CG 5503 used for?

CG 5503, also known as tapentadol, is an investigational small molecule being studied for the treatment of osteoarthritis. It is being developed for chronic pain conditions, including osteoarthritis, pain intensity assessment, arthralgia, sciatica, and low back pain.

What does CG 5503 target?

CG 5503, or tapentadol, is a small molecule in clinical development for osteoarthritis. The specific molecular target of CG 5503 has not been disclosed in the available information.

Who makes CG 5503?

CG 5503, also known as tapentadol, is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for chronic pain conditions.

What phase is CG 5503 in?

CG 5503, or tapentadol, is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, evaluating its safety in patients with chronic pain.

What clinical trials is CG 5503 in?

CG 5503, also known as tapentadol, has one completed Phase 3 clinical trial (NCT00364546). This study evaluated the 90-day safety of tapentadol immediate release compared to oxycodone immediate release in 877 patients with chronic pain, including osteoarthritis.

Is CG 5503 the same as tapentadol?

Yes, CG 5503 is the same as tapentadol. The drug is referred to by both names in clinical research. It is being developed by Johnson & Johnson for the treatment of chronic pain conditions, including osteoarthritis.