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Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02228928
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean difference in the change of daily NRS pain score [ Time Frame: 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 :
  1. Percentage of patients with >=30% or >=50% reduction in pain [ Time Frame: 6 weeks ]
    The percentage of responders (>=30% reduction) and the percentage of patients achieving a >=50% in NRS pain scores were compared among groups

  2. Daily Sleep Interference Scale [ Time Frame: 2, 4, 6 weeks ]
  3. Clinical Global Impression for Improvement [ Time Frame: 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

  4. EQ-5D [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228928


Locations
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Korea, Republic of
Seoul National University Hospital, Seoula National University Bundang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02228928    
Other Study ID Numbers: CAPNP201
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: September 2014
Keywords provided by Samyang Biopharmaceuticals Corporation:
Peripheral Nerve Injury
Postherpetic Neuralgia
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Trauma, Nervous System
Wounds and Injuries
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs