Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital, Seoula National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo patch	Other: Placebo patch
Experimental: CAPNP, 50 ug/cm2 capsaicin patch; 50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days	Drug: CAPNP, 50 ug/cm2 capsaicin patch
Experimental: CAPNP, 100 ug/cm2 capsaicin patch; 100ug/cm2 capsaicin patch, 49cm2, 1patch/4days	Drug: CAPNP, 100 ug/cm2 capsaicin patch
Active Comparator: 0.075% capsaicin cream; capsaicin cream qc/day	Drug: 0.075% capsaicin cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference in the change of daily NRS pain score	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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with >=30% or >=50% reduction in pain	The percentage of responders (>=30% reduction) and the percentage of patients achieving a >=50% in NRS pain scores were compared among groups	6 weeks
Daily Sleep Interference Scale		2, 4, 6 weeks
Clinical Global Impression for Improvement	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	2, 4, 6 weeks
EQ-5D	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	6 weeks

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Postherpetic Neuralgia; Peripheral Nerve Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Neuralgia; Neuralgia, Postherpetic; Peripheral Nerve Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: CAPNP201