- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00233155
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
March 4, 2008 updated by: NeurogesX
A Multicenter, Open-Label, Phase 2 Study of NGX-4010 for the Treatment of Neuropathic Pain in Patients With Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for the treatment of painful HIV-AN and PHN.
Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Study C118 is a multicenter, open-label, single-arm study for subjects who successfully completed a previous NGX-4010 study and have not received open-label or blinded NGX-4010 study patches within the 12 weeks prior to study entry.
One hundred eligible subjects will receive an initial open-label NGX-4010 study patch application and up to three additional open-label NGX-4010 applications at intervals of no less than 12 weeks, based on the presence or return of pain.
Eligible subjects will have moderate to severe neuropathic pain secondary to HIV-AN or PHN, with average pain levels deemed appropriate for further treatment with NGX-4010 as judged by the Investigator.
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Summary eligibility criteria:
- Subjects must be in good health and have successfully completed a past trial of NGX-4010 with no past occurrence of adverse events that would contraindicate further treatment.
- The time between the last study patch on the previous study and the first study patch on this study must be at least 12 weeks.
- Topical pain medications are exclusionary and require washout prior to study patch application for this study.
- Chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application.
- Other specific inclusion and exclusion criteria must be met prior to enrollment on the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mean percent change from baseline in "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 12 and 48, compared to baseline).
|
Secondary Outcome Measures
Outcome Measure |
---|
Proportion of subjects who score 2 or 3 ("Much Improved" or "Very Much Improved") on Patient Impression of Change at Weeks 12, 24, 36 and 48.
|
Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeffrey Tobias, MD, NeurogesX
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
October 3, 2005
First Submitted That Met QC Criteria
October 3, 2005
First Posted (Estimate)
October 5, 2005
Study Record Updates
Last Update Posted (Estimate)
March 6, 2008
Last Update Submitted That Met QC Criteria
March 4, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Varicella Zoster Virus Infection
- Neuralgia
- Peripheral Nervous System Diseases
- Nervous System Diseases
- Herpes Zoster
- Neuralgia, Postherpetic
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- C118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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