Back to resultsStudy of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
Primary Purpose
Peripheral Nerve Injury, Postherpetic Neuralgia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CAPNP, 50 ug/cm2 capsaicin patch
CAPNP, 100 ug/cm2 capsaicin patch
0.075% capsaicin cream
Placebo patch
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring Peripheral Nerve Injury, Postherpetic Neuralgia
Eligibility 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
Sites / Locations
- Seoul National University Hospital, Seoula National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
CAPNP, 50 ug/cm2 capsaicin patch
CAPNP, 100 ug/cm2 capsaicin patch
0.075% capsaicin cream
Placebo patch
Arm Description
50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
capsaicin cream qc/day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Daily Sleep Interference Scale
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
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
Full Information
NCT ID
NCT02228928
First Posted
August 26, 2014
Last Updated
April 27, 2017
Sponsor
Samyang Biopharmaceuticals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02228928
Brief Title
Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samyang Biopharmaceuticals Corporation
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury, Postherpetic Neuralgia
Keywords
Peripheral Nerve Injury, Postherpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAPNP, 50 ug/cm2 capsaicin patch
Arm Type
Experimental
Arm Description
50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
Arm Title
CAPNP, 100 ug/cm2 capsaicin patch
Arm Type
Experimental
Arm Description
100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
Arm Title
0.075% capsaicin cream
Arm Type
Active Comparator
Arm Description
capsaicin cream qc/day
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CAPNP, 50 ug/cm2 capsaicin patch
Intervention Type
Drug
Intervention Name(s)
CAPNP, 100 ug/cm2 capsaicin patch
Intervention Type
Drug
Intervention Name(s)
0.075% capsaicin cream
Intervention Type
Other
Intervention Name(s)
Placebo patch
Primary Outcome Measure Information:
Title
Mean difference in the change of daily NRS pain score
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients with >=30% or >=50% reduction in pain
Description
The percentage of responders (>=30% reduction) and the percentage of patients achieving a >=50% in NRS pain scores were compared among groups
Time Frame
6 weeks
Title
Daily Sleep Interference Scale
Time Frame
2, 4, 6 weeks
Title
Clinical Global Impression for Improvement
Description
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
Time Frame
2, 4, 6 weeks
Title
EQ-5D
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital, Seoula National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28158151
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain
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