Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain (NCT02228928) | Clinical Trial Compass
CompletedPhase 1/2
Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
South Korea60 participantsStarted 2009-02
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients who are 18 years of age or older aged having chronic peripheral neuropathy related with a diagnosis of either PHN or DPN
* patients with chronic peripheral neuropathic pain for more than 3 months with an 11-pointed Numeric Rating Scale (NRS) pain score ≥ 4
* patients with a diagnosis of PHN were eligible if at least 3 months had elapsed since shingles vesicle crusting
* patients with DPN and well controlled diabetes were asked to maintain a stable dose of oral hypoglycemic or insulin during the study period
* patients taking concomitant pain medications such as anticonvulsants, antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment
* any conservative therapies such as TENS, physical therapy, chiropractic, massage, biofeedback, or yoga were stopped at least 5 weeks before the enrollment
* women of childbearing age were required to have a negative pregnancy test and were to be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication
Exclusion Criteria:
* diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area
* significant pain of an etiology other than PHN or DNP
* other severe acute or chronic medical or psychiatric condition, or laboratory abnorm…
What they're measuring
1
Mean difference in the change of daily NRS pain score