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Peripheral Nervous System DiseasesPhase 3NCT00115310

Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

A Phase 3 study testing NGX-4010 in people with Peripheral Nervous System Diseases and Pain, 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 is to assess the efficacy and safety of NGX-4010 applied for 60 minutes for the treatment of postherpetic neuralgia (PHN). Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
NGX-4010
How many people
400 participants
Where
No sites listed yet
Study dates
Jun 2005to Oct 2006
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of PHN, with at least 6 months of pain since shingles vesicle crusting
  • Average NPRS scores for PHN-associated pain during screening period of 3 to 9
  • 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 Study Patch Application Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout study
  • Female subjects with child-bearing potential must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, within 7 days of Study Patch Application Visit
  • All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study (or, in the event of early termination from the study, for 30 days following experimental drug exposure)
  • Be willing and able to comply with protocol requirements for the duration of study participation.
  • Subjects must sign an informed consent form for this study approved by the Investigator's Institutional Review Board/Independent Ethics Committee (IRB/IEC).

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 study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort, as judged by Investigator.
  • Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by Investigator.
  • Recent use (within 21 days preceding the Study Patch Application Visit [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 the painful areas.
  • Participation in a previous NeurogesX clinical trial in which subject received NGX-4010 (either blinded or open-label study treatment).
  • Current use of any investigational agent, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
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  • Diabetes mellitus, unless well-controlled as evidenced by an HbA1c level less than or equal to 9%.
  • Hypertension, unless adequately controlled by medication.
  • Significant pain of an etiology other than PHN. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN-related pain.
  • Painful PHN areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
  • Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  • Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oxycodone hydrochloride, hydrocodone bitartrate or adhesives.
  • 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.
  • Recent history of a significant medical-surgical intervention in the judgment of the Investigator.
  • Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring subject's recall of average PHN pain level in the past 24 hours.

About this study

Official title: A Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60 minutes for the treatment of postherpetic neuralgia (PHN).

Read the detailed description

This study is a 12-week randomized, double-blind, controlled multi-center evaluation of the efficacy, safety and tolerability of NGX-4010 for the treatment of PHN. Eligible subjects will have moderate to severe pain from PHN, with average NPRS scores during screening of 3 to 9 (inclusive). Painful areas of up to 1000 square centimeters will be treated during a single treatment administration in this study. Subjects will be randomly assigned to receive active NGX-4010 patches or low-concentration control patches that are identical in appearance, according to a 1:1 allocation scheme.

Subjects may be on stable chronic oral pain medication regimens, but currently will not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours will be recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects will continue 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 will return for interim follow-up visits at Weeks 4 and 8 following study treatment.

Being tested
NGX-4010
Keywords
dermal assessment, pain measurement, diary, PHN, shingles, neuropathy, analgesics, capsaicin, postherpetic neuralgia
Medical subject headings
Peripheral Nervous System Diseases, Pain, Neuralgia, Herpes Zoster, Neuralgia, Postherpetic

What participants receive

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

  • NGX-4010Drug

What is being measured

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

  1. Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 8, compared to baseline) in the active group compared to the control group

Secondary outcomes (10)

  1. Percent change from baseline in "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 2 to 4 and 2 to 12, respectively, compared to baseline) in the active group compared to the control group

  2. Proportion of subjects reaching 30% and 50% decrease, respectively, from baseline in "average pain for the past 24 hours" NPRS scores on average during Weeks 2 to 8

  3. Proportion of subjects reaching 30% and 50% decrease, respectively, from baseline in "average pain for the past 24 hours" NPRS scores on average during Weeks 2 to 4 and 2 to 12, respectively

  4. Median onset and mean duration of efficacy in days in the active group

  5. Proportion of subjects with significant changes in concomitant pain medication usage during Weeks 2 to 8, compared to baseline

  6. Brief Pain Inventory (BPI)

  7. Short-Form McGill Pain Questionnaire (SF-MPQ)

  8. Subject Global Impression of Change (PGIC)

  9. Self-Assessment of Treatment (SAT)

  10. Short-Form 36v2 Health Survey (SF-36v2™)

Timeline

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

  1. First posted22 Jun 2005 (estimated)
  2. Study startJun 2005
  3. Study completionOct 2006

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
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115310
Sponsor's protocol ID
C116
Status last verified
Mar 2008
First submitted
21 Jun 2005
Last updated
6 Mar 2008
Results posted
No

Publications

  • Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan P Jr, Rauck R, Tobias J; NGX-4010 C116 Study Group. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008 Dec;7(12):1106-12. doi: 10.1016/S1474-4422(08)70228-X. Epub 2008 Oct 30.

    PubMed 18977178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NGX-4010 in people with Peripheral Nervous System Diseases and Pain, 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 8 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 6 Mar 2008. 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?

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 "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 8, compared to baseline) in the active group compared to the control group. 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 NCT00115310, 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 6 Mar 2008.

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