Clinical trial NCT02228928: Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Nerve Injury
Postherpetic Neuralgia
Keywords: Peripheral Nerve Injury
Postherpetic Neuralgia
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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 abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study
* painful PHN areas located on the face or above the scalp hairline
* an implanted medical device for the treatment of neuropathic pain
* use of topically applied agents including capsaicin-containing products, a 5% lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days
* hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug; and uncontrolled diabetes mellitus or uncontrolled hypertension
* If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2 weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day

Primary outcomes:
measure: Mean difference in the change of daily NRS pain score
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of patients with >=30% or >=50% reduction in pain
timeFrame: 6 weeks
measure: Daily Sleep Interference Scale
timeFrame: 2, 4, 6 weeks
measure: Clinical Global Impression for Improvement
timeFrame: 2, 4, 6 weeks
measure: EQ-5D
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Seoula National University Bundang Hospital
Study officials:
References:
citation: Moon JY, Lee PB, Kim YC, Lee SC, Nahm FS, Choi E. Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in Peripheral Neuropathic Pain: Multi-Center, Randomized, and Semi-Double Blind Controlled Study. Pain Physician. 2017 Feb;20(2):27-35.