PainPhase 3NCT00321672

Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

A Phase 3 study testing NGX-4010, 8% capsaicin patch and 0.04% capsaicin patch in people with Pain and HIV Infections, run by NeurogesX.

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 purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, HIV Infections, Peripheral Nervous System Diseases
What is being tested?: NGX-4010, 8% capsaicin patch and 0.04% capsaicin patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 494 participants
Where: No sites listed yet
Study dates: Jun 2006to Dec 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Documented evidence of HIV-1 infection
Documented diagnosis of painful HIV-associated distal symmetric polyneuropathy resulting from HIV disease and/or antiretroviral drug exposure To be confirmed based on symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, AND absent or diminished ankle reflexes OR at least one of following: distal diminution of vibration sensation or pain or temperature sensation in legs
Average NPRS scores during screening period of 3 to 9, inclusive
Life expectancy of 12 months or longer per Investigator's judgment
Intact, unbroken skin over painful areas to be treated
If taking chronic pain medications, be on stable regimen for at least 21 days prior to Day 0 and willing to maintain medications at same stable dose(s) and schedule throughout study

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Female subjects with child-bearing potential: negative serum pregnancy test performed at Screening Visit
Willing to use effective methods of birth control and/or refrain from conception process during study and for 30 days following study drug exposure
Willing and able to comply with protocol for duration of study

Who cannot join

Concomitant opioid medication, unless orally or transdermally administered and not exceeding total daily dose of morphine 80 mg/day or equivalent; parenteral opioids not allowed
Unavailability of effective rescue medication strategy for subject, such as unwillingness to use opioid analgesics during study treatment or high tolerance to opioids precluding ability to relieve treatment-associated discomfort as judged by investigator
Active substance abuse or history of chronic substance abuse within past year or prior chronic substance abuse (including alcoholism) judged likely to recur during study period by investigator
Recent use (within 21 days preceding Day 0) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin products on painful areas
Started or stopped treatment with one or more neurotoxic antiretroviral agents (ie, didanosine [ddI], zalcitabine [ddC], or stavudine [d4T] during 8 weeks prior to Day 0
Participation in previous clinical trial in which subject received either blinded or open-label NGX-4010

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Current use of any investigational agent or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine)
Evidence of another contributing cause for peripheral neuropathy, e.g., current uncontrolled diabetes mellitus (HbA1c≥9%) or history of diabetes mellitus preceding onset of HIV-associated neuropathy (HIV-AN); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤200pg/mL at screening); or treatment within 90 days prior to Screening Visit with any drug that may have contributed to sensory neuropathy
Hypertension, unless adequately controlled by medication
Significant ongoing pain from other cause(s) that may interfere with judging HIV-AN related pain
Any implanted medical device for treatment of neuropathic pain
Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter (OTC) capsaicin products), local anesthetics, opioid-based oral analgesics or adhesives
Significant medical conditions (including active malignancy defined as treatment required in last 5 years) that in opinion of investigator would interfere with ability to complete study or evaluation of AEs
Recent significant medical-surgical intervention that in judgment of Investigator would interfere with ability to complete study or evaluation of AEs; examples include to major surgery, or receipt of immunosuppressive therapy within 3 months prior to Day 0
Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average HIV-associated neuropathy pain level in past 24 hours

About this study

Official title: A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Read the detailed description

Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study. Subjects were randomly assigned to receive active NGX-4010 patches (8% capsaicin) or low-concentration control patches (0.04% capsaicin) identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2:1:2:1 allocation scheme.

Subjects could be on stable chronic oral pain medication regimens, but could not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours were recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects continued to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study treatment.

Conditions: Pain, HIV Infections, Peripheral Nervous System Diseases
Being tested: NGX-4010, 8% capsaicin patch, 0.04% capsaicin patch
Keywords: Analgesics, Capsaicin, Neuropathic pain, Neuropathy, Distal sensory polyneuropathy, Peripheral neuropathy, Dermal assessment, Pain measurement
Medical subject headings: Pain, HIV Infections, Peripheral Nervous System Diseases, Neuralgia

What participants receive

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

NGX-4010, 8% capsaicin patchDrug
Also called the brandname of NGX-4010, 8% capsaicin patch is Qutenza.
Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
0.04% capsaicin patchDrug
Also called NGX-4010
Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.
NGX-4010, 8% capsaicin patchDrug
Also called The brandname of NGX-4010, 8% capsaicin patch is Qutenza.
Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.
0.04% capsaicin patchDrug
Also called NGX-4010
Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.

Study groups in NCT00321672
Study group	Role	What they receive
NGX-4010, 60 minutes	Experimental	Not described Receives: Drug: NGX-4010, 8% capsaicin patch
NGX-4010, 30 minutes	Experimental	Not described Receives: Drug: NGX-4010, 8% capsaicin patch
0.04% conc. capsaicin patch, 60 min.	Other	Not described Receives: Drug: 0.04% capsaicin patch
0.04% conc. capsaicin patch, 30 min.	Other	Not described Receives: Drug: 0.04% capsaicin patch

What is being measured

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

The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.
Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing "average pain for the past 24 hours" for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
Measured: Weeks 2-12

Secondary outcomes (2)

Absolute Change in the Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.
Measured: Weeks 2-12.
Proportion of Subjects Reaching 30% Decrease in Their Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12
Measured: Weeks 2-12

Timeline

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

Jun 2006Dec 2007

First posted4 May 2006 (estimated)
Study startJun 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PainStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00321672
Sponsor's protocol ID: C119
Status last verified: May 2011
First submitted: 2 May 2006
Last updated: 14 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Brown S, Simpson DM, Moyle G, Brew BJ, Schifitto G, Larbalestier N, Orkin C, Fisher M, Vanhove GF, Tobias JK. NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials. AIDS Res Ther. 2013 Jan 28;10(1):5. doi: 10.1186/1742-6405-10-5.
PubMed 23351618
Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, Tobias JK, Vanhove GF; NGX-4010 C119 Study Group. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):126-33. doi: 10.1097/QAI.0b013e31823e31f7.
PubMed 22067661

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
ClinicalTrials.gov ID: NCT00321672
Acronym / sponsor ID: C119
Conditions: Pain, HIV Infections, Peripheral Nervous System Diseases
Keywords: Analgesics, Capsaicin, Neuropathic pain, Neuropathy, Distal sensory polyneuropathy, Peripheral neuropathy, Dermal assessment, Pain measurement
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 494 participants (actual)
Lead sponsor: NeurogesXIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 4 May 2006 (estimated)
Results: Posted 14 Jun 2011

Clinical summary

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

The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
NGX-4010, 60 minutes	Experimental	Drug: NGX-4010, 8% capsaicin patch
NGX-4010, 30 minutes	Experimental	Drug: NGX-4010, 8% capsaicin patch
0.04% conc. capsaicin patch, 60 min.	Other	Drug: 0.04% capsaicin patch
0.04% conc. capsaicin patch, 30 min.	Other	Drug: 0.04% capsaicin patch

Who may qualify

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

Key inclusion criteria (9 listed)

Documented evidence of HIV-1 infection
Documented diagnosis of painful HIV-associated distal symmetric polyneuropathy resulting from HIV disease and/or antiretroviral drug exposure To be confirmed based on symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, AND absent or diminished ankle reflexes OR at least one of following: distal diminution of vibration sensation or pain or temperature sensation in legs
Average NPRS scores during screening period of 3 to 9, inclusive
Life expectancy of 12 months or longer per Investigator's judgment
Intact, unbroken skin over painful areas to be treated

Key exclusion criteria (15 listed)

Concomitant opioid medication, unless orally or transdermally administered and not exceeding total daily dose of morphine 80 mg/day or equivalent; parenteral opioids not allowed
Unavailability of effective rescue medication strategy for subject, such as unwillingness to use opioid analgesics during study treatment or high tolerance to opioids precluding ability to relieve treatment-associated discomfort as judged by investigator
Active substance abuse or history of chronic substance abuse within past year or prior chronic substance abuse (including alcoholism) judged likely to recur during study period by investigator
Recent use (within 21 days preceding Day 0) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin products on painful areas
Started or stopped treatment with one or more neurotoxic antiretroviral agents (ie, didanosine [ddI], zalcitabine [ddC], or stavudine [d4T] during 8 weeks prior to Day 0

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
NGX-4010, 8% capsaicin patchAlso: the brandname of NGX-4010, 8% capsaicin patch is Qutenza.Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.	Drug	NGX-4010, 60 minutes
0.04% capsaicin patchAlso: NGX-4010Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 60 minutes.	Drug	0.04% conc. capsaicin patch, 60 min.
NGX-4010, 8% capsaicin patchAlso: The brandname of NGX-4010, 8% capsaicin patch is Qutenza.Up to 4 NGX-4010 patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.	Drug	NGX-4010, 30 minutes
0.04% capsaicin patchAlso: NGX-4010Up to 4 control patches of 280 cm^2 each were applied to the feet (2 per foot) for 30 minutes.	Drug	0.04% conc. capsaicin patch, 30 min.

Primary outcome

The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.
Time frame: Weeks 2-12
Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing "average pain for the past 24 hours" for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.

2 secondary outcomes

Absolute Change in the Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.
Time frame: Weeks 2-12.
Proportion of Subjects Reaching 30% Decrease in Their Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12
Time frame: Weeks 2-12

Results and safety

Results posted to the registry on 14 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NGX-4010, 60 Minutes	165	153
Control Group, 60 Minutes	89	81
NGX-4010, 30 Minutes	167	156
Control Group , 30 Minutes	73	71

Primary outcome: The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.

Time frame: Weeks 2-12. Least squares mean (Standard Error). Unit: Percent Change from baseline

Measure	NGX-4010, 60 Minutes n = 165	Control Group, 60 Minutes n = 90	NGX-4010, 30 Minutes n = 167	Control Group , 30 Minutes n = 72	NGX-4010 Total n = 332	Control, Total n = 162
Value	-32.8 (2.41)	-30.0 (3.27)	-26.2 (2.39)	-19.1 (3.61)	-29.5 (1.70)	-24.5 (2.43)

NGX-4010 Total vs Control, Total: p = 0.0967, ANCOVA
NGX-4010, 60 Minutes vs Control Group, 60 Minutes: p = 0.4884, ANCOVA
NGX-4010, 30 Minutes vs Control Group , 30 Minutes: p = 0.1031, ANCOVA

Population analysed: Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NGX-4010, 60 Minutes	13 of 165 (7.9%)	160 of 165 (97%)	Not reported
Control Group, 60 Minutes	7 of 90 (7.8%)	73 of 90 (81.1%)	Not reported
NGX-4010, 30 Minutes	6 of 167 (3.6%)	149 of 167 (89.2%)	Not reported
Control Group , 30 Minutes	2 of 72 (2.8%)	61 of 72 (84.7%)	Not reported
NGX-4010 Total	19 of 332 (5.7%)	309 of 332 (93.1%)	Not reported
Control, Total	9 of 162 (5.6%)	134 of 162 (82.7%)	Not reported

Limitations and caveats (from the sponsor): Differences between the 60- and 30-minute Control groups prevented pooling according to prespecified criteria resulting in treatment comparisons between 60- and 30-minute NGX-4010 groups and their respective Control groups with relatively low power.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23351618Brown S, Simpson DM, Moyle G, Brew BJ, Schifitto G, Larbalestier N, Orkin C, Fisher M, Vanhove GF, Tobias JK. NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials. AIDS Res Ther. 2013 Jan 28;10(1):5. doi: 10.1186/1742-6405-10-5.
Derived from this study: PubMed 22067661Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, Tobias JK, Vanhove GF; NGX-4010 C119 Study Group. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):126-33. doi: 10.1097/QAI.0b013e31823e31f7.

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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.

Trudy F Vanhove, MD study director

NeurogesX

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NGX-4010, 8% capsaicin patch and 0.04% capsaicin patch in people with Pain and HIV Infections, run by NeurogesX.

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 9 inclusion and 15 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 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12. (time frame: Weeks 2-12). 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 NCT00321672, which also lists 2 linked publications.

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 14 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.