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CG5503

Phase 3

Diabetic Neuropathy | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jul 19, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment395

FDA Designations

No designations recorded

Clinical trial landscape

CG5503 · 1 trial · 1 indication

Phase 3 1
NCT00455520A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral NeuropathyDiabetic Neuropathy
COMPLETED395 Analytics
PHASE3COMPLETED
A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
Diabetic Neuropathy
NCT00455520395
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Study Endpoints

Primary Endpoints

Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12
Baseline and 12 weeks

For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

Secondary Endpoints

The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.
Start of Open Label and at 12 weeks of Double Blind
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
12 week endpoint
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
12 week endpoint (change from baseline)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORplacebo matching placebo twice daily for 12 weeks
CG5503EXPERIMENTALCG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks

Interventions

NameTypeDescription
CG5503DRUG100, 150, 200, 250 mg twice daily given for up to 15 weeks
placeboDRUGmatching placebo twice daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with Type 1 or Type 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening * The investigator considers the patient's blood glucos...

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Frequently asked questions about CG5503

What is CG5503 used for?

CG5503 is an investigational small molecule being developed for diabetic neuropathy. It is being studied as a treatment for painful diabetic peripheral neuropathy, a condition involving nerve damage and pain caused by diabetes. The drug is currently in Phase 3 clinical development.

What does CG5503 target?

CG5503 is a small molecule developed by Johnson & Johnson. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its safety and efficacy in treating painful diabetic peripheral neuropathy.

Who makes CG5503?

CG5503 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy for diabetic neuropathy.

What phase is CG5503 in?

CG5503 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is not yet approved and remains investigational, with no active trials currently ongoing.

What clinical trials is CG5503 in?

CG5503 has one completed Phase 3 clinical trial, identified as NCT00455520. This study evaluated the safety and efficacy of CG5503 extended release for patients with painful diabetic peripheral neuropathy. The trial enrolled 395 participants and was randomized, double-blind, and placebo-controlled.

Is CG5503 the same as tapentadol?

CG5503 is the investigational code name for tapentadol. The completed Phase 3 trial, NCT00455520, was titled 'A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy,' confirming that CG5503 and tapentadol refer to the same drug.