Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Phase 1

Completed

• Conditions: Peripheral Nerve Injury; Postherpetic Neuralgia
• Interventions: Drug: CAPNP, 100 ug/cm2 capsaicin patch; Drug: 0.075% capsaicin cream; Drug: CAPNP, 50 ug/cm2 capsaicin patch; Other: Placebo patch

• Registration Number: NCT02228928
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-08-29
• Status Verified: 2014-09
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAPNP, 100 ug/cm2 capsaicin patch	CAPNP, 100 ug/cm2 capsaicin patch	100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
0.075% capsaicin cream	0.075% capsaicin cream	capsaicin cream qc/day
CAPNP, 50 ug/cm2 capsaicin patch	CAPNP, 50 ug/cm2 capsaicin patch	50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
Placebo patch	Placebo patch	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
EQ-5D	6 weeks	For EQ-5DTM Health Survey, mean change from the baseline (Visit 2) to the score at weeks 6 (Visit 5) was shown as frequencies and their percentages
Daily Sleep Interference Scale	2, 4, 6 weeks
Percentage of patients with >=30% or >=50% reduction in pain	6 weeks	The percentage of responders (\>=30% reduction) and the percentage of patients achieving a \>=50% in NRS pain scores were compared among groups
Clinical Global Impression for Improvement	2, 4, 6 weeks	Clinical Global Impression of Change by the physician and Patient Global Impression of Change by the patients were used to evaluate the subjective perception of decrease in pain intensity

Trial Locations

Locations (1)

Seoul National University Hospital, Seoula National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of