Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in the Management of Peripheral Neuropathic Pain ; Early Phase II, Multi-center, Randomized, and Semi-double Blind Controlled Clinical Trial

NCT02228928 Phase 1/Phase 2 COMPLETED

The efficacy and safety of the low concentration \[0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)\] capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy

Details

Lead sponsor	Samyang Biopharmaceuticals Corporation
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	60
Start date	2009-02
Completion	2011-05

Conditions

• Peripheral Nerve Injury
• Postherpetic Neuralgia

Interventions

• CAPNP, 50 ug/cm2 capsaicin patch
• CAPNP, 100 ug/cm2 capsaicin patch
• 0.075% capsaicin cream
• Placebo patch

Primary outcomes

• Mean difference in the change of daily NRS pain score — 6 weeks
  Mean numeric change in numerical rating scale pain score from the baseline (Visit 2) to the score at weeks 6 (Visit 5) in each group

Countries

South Korea