Trials Sponsors Conditions Drugs Pricing

Conditions

Pain HIV Infections Peripheral Nervous System Diseases

Keywords

AnalgesicsCapsaicinNeuropathic painNeuropathyDistal sensory polyneuropathyPeripheral neuropathyDermal assessmentPain measurement

Outcome Measures

Primary Outcomes (1)

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.
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.
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

Study Arms (4)

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

Interventions

NGX-4010, 8% capsaicin patchDrug

Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

Also known as: the brandname of NGX-4010, 8% capsaicin patch is Qutenza.

NGX-4010, 60 minutes

0.04% capsaicin patchDrug

Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

NeurogesX
Industrylead

Related Publications (2)

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.
PMID: 23351618DERIVED
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.
PMID: 22067661DERIVED

MeSH Terms

Conditions

PainHIV InfectionsPeripheral Nervous System DiseasesNeuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus Infections

Limitations and Caveats

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.

Results Point of Contact

Title: Trudy Vanhove, VP Clinical Development
Organization: NeurogesX

Study Officials

Trudy F Vanhove, MD
NeurogesX
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

494 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

June 2006

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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
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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

NGX-4010, 60 minutes

NGX-4010, 30 minutes

0.04% conc. capsaicin patch, 60 min.

0.04% conc. capsaicin patch, 30 min.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

NGX-4010, 60 minutes

NGX-4010, 30 minutes

0.04% conc. capsaicin patch, 60 min.

0.04% conc. capsaicin patch, 30 min.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record