Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Sponsor

Samyang Biopharmaceuticals Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02228928

Collaborator

(none)

Enrollment

Location

Arms

26.9

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Injury Postherpetic Neuralgia	Drug: CAPNP, 50 ug/cm2 capsaicin patch Drug: CAPNP, 100 ug/cm2 capsaicin patch Drug: 0.075% capsaicin cream Other: Placebo patch	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo patch	Other: Placebo patch

Outcome Measures

Primary Outcome Measures

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

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
Daily Sleep Interference Scale [2, 4, 6 weeks]
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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