Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

NCT02228928 | Completed Phase 1

• 1 other identifier: CAPNP201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Nerve Injury; Postherpetic Neuralgia

Keywords

Peripheral Nerve Injury; Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of patients with >=30% or >=50% reduction in pain

  6 weeks

• Daily Sleep Interference Scale

  2, 4, 6 weeks

• Clinical Global Impression for Improvement

  2, 4, 6 weeks

• EQ-5D

  6 weeks

Study Arms (4)

CAPNP, 50 ug/cm2 capsaicin patch

EXPERIMENTAL

50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days

Drug: CAPNP, 50 ug/cm2 capsaicin patch

CAPNP, 100 ug/cm2 capsaicin patch

EXPERIMENTAL

100ug/cm2 capsaicin patch, 49cm2, 1patch/4days

Drug: CAPNP, 100 ug/cm2 capsaicin patch

0.075% capsaicin cream

ACTIVE COMPARATOR

capsaicin cream qc/day

Drug: 0.075% capsaicin cream

Placebo patch

PLACEBO COMPARATOR

Other: Placebo patch

Interventions

CAPNP, 50 ug/cm2 capsaicin patch DRUG

CAPNP, 50 ug/cm2 capsaicin patch

CAPNP, 100 ug/cm2 capsaicin patch DRUG

CAPNP, 100 ug/cm2 capsaicin patch

0.075% capsaicin cream DRUG

0.075% capsaicin cream

Placebo patch OTHER

Placebo patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Seoul National University Hospital, Seoula National University Bundang Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28158151 DERIVED

MeSH Terms

Conditions

Peripheral Nerve Injuries; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 29, 2014
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 1, 2017

Record last verified: 2014-09

Locations

KR (1)