Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Postherpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228928
• Other study ID #: CAPNP201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 26, 2014
• Last updated: April 27, 2017
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: September 2014
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Postherpetic Neuralgia

Intervention

Drug:
• CAPNP, 50 ug/cm2 capsaicin patch

• CAPNP, 100 ug/cm2 capsaicin patch

• 0.075% capsaicin cream

Other:
• Placebo patch

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Seoula National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Daily Sleep Interference Scale		2, 4, 6 weeks
Secondary	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
Secondary	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