Peripheral Nerve InjuryPhase 1/2NCT02228928

Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

A Phase 1/2 study testing CAPNP, 50 ug/cm2 capsaicin patch, CAPNP, 100 ug/cm2 capsaicin patch and 0.075% capsaicin cream in people with Peripheral Nerve Injury and Postherpetic Neuralgia, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Nerve Injury, Postherpetic Neuralgia
What is being tested?: CAPNP, 50 ug/cm2 capsaicin patch, CAPNP, 100 ug/cm2 capsaicin patch and 0.075% capsaicin cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteSouth Korea
Study dates: Feb 2009to May 2011
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital, Seoula National University Bundang Hospital
Seoul

Other trials in South Korea

About this study

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

Conditions: Peripheral Nerve Injury, Postherpetic Neuralgia
Being tested: CAPNP, 50 ug/cm2 capsaicin patch, CAPNP, 100 ug/cm2 capsaicin patch, 0.075% capsaicin cream, Placebo patch
Keywords: Peripheral Nerve Injury, Postherpetic Neuralgia
Medical subject headings: Peripheral Nerve Injuries, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CAPNP, 50 ug/cm2 capsaicin patchDrug
CAPNP, 100 ug/cm2 capsaicin patchDrug
0.075% capsaicin creamDrug
Placebo patchOther

Study groups in NCT02228928
Study group	Role	What they receive
CAPNP, 50 ug/cm2 capsaicin patch	Experimental	50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days Receives: Drug: CAPNP, 50 ug/cm2 capsaicin patch
CAPNP, 100 ug/cm2 capsaicin patch	Experimental	100ug/cm2 capsaicin patch, 49cm2, 1patch/4days Receives: Drug: CAPNP, 100 ug/cm2 capsaicin patch
0.075% capsaicin cream	Active comparator	capsaicin cream qc/day Receives: Drug: 0.075% capsaicin cream
Placebo patch	Placebo comparator	Not described Receives: Other: Placebo patch

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 weeks

Secondary outcomes (4)

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
Measured: 6 weeks
Daily Sleep Interference Scale
Measured: 2, 4, 6 weeks
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
Measured: 2, 4, 6 weeks
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
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009May 2011

First posted29 Aug 2014 (estimated)
Study startFeb 2009
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02228928
Sponsor's protocol ID: CAPNP201
Status last verified: Sep 2014
First submitted: 26 Aug 2014
Last updated: 1 May 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 28158151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Nerve Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02228928
Acronym / sponsor ID: CAPNP201
Conditions: Peripheral Nerve Injury, Postherpetic Neuralgia
Keywords: Peripheral Nerve Injury, Postherpetic Neuralgia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 29 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
CAPNP, 50 ug/cm2 capsaicin patch	Experimental	Drug: CAPNP, 50 ug/cm2 capsaicin patch50 ug/cm2 capsaicin patch, 49cm2, 1patch/4days
CAPNP, 100 ug/cm2 capsaicin patch	Experimental	Drug: CAPNP, 100 ug/cm2 capsaicin patch100ug/cm2 capsaicin patch, 49cm2, 1patch/4days
0.075% capsaicin cream	Active comparator	Drug: 0.075% capsaicin creamcapsaicin cream qc/day
Placebo patch	Placebo comparator	Other: Placebo patch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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

Primary outcome

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

4 secondary outcomes

Percentage of patients with >=30% or >=50% reduction in pain
Time frame: 6 weeks
Daily Sleep Interference Scale
Time frame: 2, 4, 6 weeks
Clinical Global Impression for Improvement
Time frame: 2, 4, 6 weeks
EQ-5D
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
Derived from this study: PubMed 28158151Moon 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.

Related trials for Peripheral Nerve Injury

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference in the change of daily NRS pain score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02228928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.