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HIV InfectionsPhase 3NCT00064623

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

A Phase 3 study testing Capsaicin Dermal Patch in people with HIV Infections and Peripheral Nervous System Diseases, run by NeurogesX at 35 sites in United States.

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 is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capsaicin Dermal Patch
How many people
300 participants
Where
35 sitesUnited States
Study dates
Aug 2003to Nov 2005
Phase
Phase 3
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

  • At least 18 years of age
  • Documented evidence of HIV-1 infection
  • Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy established by a neurologist resulting from HIV disease and/or antiretroviral drug exposure, with primary 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, and at least one of the following: distal diminution of vibration sensation or pain or temperature sensation in the legs
  • Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit
  • Screening Pain Sum Score of 12 to 36
  • Karnofsky Performance Score of greater than or equal to 60
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  • Intact, unbroken skin over the painful area(s) to be treated
  • If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit and willing to maintain these medications at the same stable dose(s) and schedule throughout the study
  • 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 participating in a conception process during study and for 30 days following experimental drug exposure
  • Willing and able to comply with protocol requirements for duration of study

Who cannot join

  • Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose
  • Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone® or Vicodin®, as judged by the Investigator
  • Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator
  • Recent use (within 21 days preceding the Treatment Visit of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas
  • Current use of any investigational agent or Class 1 anti-arrhythmic drugs
  • Significant pain of an etiology other than painful HIV-associated neuropathy; significant ongoing pain from other cause(s) that may interfere with judging HIV-associated neuropathy pain
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  • Evidence of another contributing cause for peripheral neuropathy, e.g., diabetes mellitus requiring medication control (i.e., oral hypoglycemics, insulin); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of B12 supplementation prior to Screening Visit; or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy
  • Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain
  • Treatment for acute opportunistic infections within 14 days before Treatment Visit
  • Presence of acute, active opportunistic infection, except oral thrush; oral, genital, or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening Visit
  • Currently have active malignant disease
  • Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
  • Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, Roxicodone®, Vicodin®, or adhesives

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • NeurogesX Investigational Site

    Albany, New York, 12208

  • NeurogesX Investigational Site

    Austin, Texas, 78705

  • NeurogesX Investigational Site

    Baltimore, Maryland, 21205

  • NeurogesX Investigational Site

    Berkeley, California, 94609

  • NeurogesX Investigational Site

    Boston, Massachusetts, 02215

  • NeurogesX Investigational Site

    Camden, New Jersey, 08103-1489

  • NeurogesX Investigational Site

    Chapel Hill, North Carolina, 27599

  • NeurogesX Investigational Site

    Chicago, Illinois, 60612

  • NeurogesX Investigational Site

    Cleveland, Ohio, 44106

  • NeurogesX Investigational Site

    Dallas, Texas, 75208

  • NeurogesX Investigational Site

    Detroit, Michigan, 48201

  • NeurogesX Investigational Site

    Fort Lauderdale, Florida, 33306

  • NeurogesX Investigational Site

    Honolulu, Hawaii, 96816

  • NeurogesX Investigational Site

    Houston, Texas, 77030

  • NeurogesX Investigational Site

    Lexington, Kentucky, 40536

  • NeurogesX Investigational Site

    Madison, Wisconsin, 53792-5132

  • NeurogesX Investigational Site

    Miami, Florida, 33133

  • NeurogesX Investigational Site

    Miami, Florida, 33136

  • NeurogesX Investigational Site

    Minneapolis, Minnesota, 55416

  • NeurogesX Investigational Site

    New York, New York, 10021

  • NeurogesX Investigational Site

    New York, New York, 10029

  • NeurogesX Investigational Site

    North Palm Beach, Florida, 33408

  • NeurogesX Investigational Site

    Orlando, Florida, 32804

  • NeurogesX Investigational Site

    Phoenix, Arizona, 85006

  • NeurogesX Investigational Site

    Phoenix, Arizona, 85023

  • NeurogesX Investigational Site

    Portland, Oregon, 97209

  • NeurogesX Investigational Site

    San Antonio, Texas, 78229

  • NeurogesX Investigational Site

    San Diego, California, 92103

  • NeurogesX Investigational Site

    San Francisco, California, 94117

  • NeurogesX Investigational Site

    Springfield, Massachusetts, 01107

  • NeurogesX Investigational Site

    St Louis, Missouri, 63108

  • NeurogesX Investigational Site

    Stanford, California, 94305

  • NeurogesX Investigational Site

    Sunrise, Florida, 33351

  • NeurogesX Investigational Site

    Vero Beach, Florida, 32960

  • NeurogesX Investigational Site

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.

Read the detailed description

The C107 study is a randomized, double-blind, controlled dose finding study of NGX-4010 for the treatment of painful symptoms of HIV-associated neuropathy. Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and to receive double-blind NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).

Participants who complete study evaluations through Week 12 will have the option of receiving up to 3 additional open-label treatments.

Being tested
Capsaicin Dermal Patch
Keywords
Dermal assessment, Pain measurement, Diary, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Peripheral Nervous System Diseases/*complications/diagnosis/*therapy, Peripheral Nervous System Diseases/drug therapy/*etiology/physiopathology
Medical subject headings
HIV Infections, Peripheral Nervous System Diseases, Pain

What participants receive

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

  • Capsaicin Dermal PatchDrug

What is being measured

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

  1. Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)

Secondary outcomes (7)

  1. Percent change from baseline in the "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 2-4 and 2-8, respectively, compared to baseline)

  2. Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-12, within each treatment group

  3. Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-4 and 2 8, respectively, within each treatment group

  4. Percent change from baseline in the "worst pain for the past 24 hours" and "pain now" NPRS scores (baseline score compared to the average of scores from Weeks 2 -12), within each treatment group

  5. "Pain now" on evening of treatment day

  6. Mean onset and duration of efficacy in days within each treatment group

  7. Proportion of subjects with significant changes in concomitant pain medication usage during Weeks 2-12, compared to baseline

Timeline

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

  1. First posted11 Jul 2003 (estimated)
  2. Study startAug 2003
  3. Study completionNov 2005

Resources

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
Double blind
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064623
Sponsor's protocol ID
C107
Status last verified
Mar 2008
First submitted
10 Jul 2003
Last updated
6 Mar 2008
Results posted
No

Publications

  • Simpson DM, Brown S, Tobias JK, Vanhove GF; NGX-4010 C107 Study Group. NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. Clin J Pain. 2014 Feb;30(2):134-42. doi: 10.1097/AJP.0b013e318287a32f.

    PubMed 23446088

  • 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

  • Simpson DM, Brown S, Tobias J; NGX-4010 C107 Study Group. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008 Jun 10;70(24):2305-13. doi: 10.1212/01.wnl.0000314647.35825.9c.

    PubMed 18541884

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capsaicin Dermal Patch in people with HIV Infections and Peripheral Nervous System Diseases, run by NeurogesX at 35 sites in United States.

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 11 inclusion and 13 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 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. 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. 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?

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?

Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline). 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 NCT00064623, which also lists 3 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 6 Mar 2008.

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