- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034710
Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
February 6, 2006 updated by: NeurogesX
A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia.
The study will also collect preliminary information on safety and efficacy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85023
- Arizona Research Center
-
Tucson, Arizona, United States, 85724
- University of Arizona Health Sciences Center
-
-
Florida
-
Naples, Florida, United States, 34102
- Anchor Research Center
-
Palm Beach Gardens, Florida, United States, 33410
- Palm Beach Neurological Center
-
St. Petersburg, Florida, United States, 33701
- Suncoast Neuroscience Associates, Inc.
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital, Pain Trials Center
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah Pain Management Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital, Neurology Department
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Eligibility Criteria
Inclusion Criteria:
Patients may be eligible for this study if they:
- Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
- Are in good health.
- Have an adequate pain score during the screening period.
- Have painful areas (maximum of two sites) below the neck.
- If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
- If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure.
- Have unbroken skin with good perfusion over the painful area(s).
- Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream.
- Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study.
- Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches.
- Are 18 years of age or older.
- Are willing and able to comply with the protocol
Exclusion Criteria:
Patients will not be eligible for this study if they:
- Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
- Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
- Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
- Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
- Currently have an abuse problem with alcohol (from self-report or as judged by investigator).
- Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician.
- Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain.
- Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician.
- Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation.
- Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives.
- Have a high tolerance to opioids.
- Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
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: RANDOMIZED
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: John A Jermano, NeurogesX
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
March 1, 2002
Study Completion
October 1, 2002
Study Registration Dates
First Submitted
May 1, 2002
First Submitted That Met QC Criteria
May 1, 2002
First Posted (ESTIMATE)
May 2, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
February 7, 2006
Last Update Submitted That Met QC Criteria
February 6, 2006
Last Verified
February 1, 2006
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
- C102
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Capsaicin Patch
-
NeurogesXCompletedHIV Infections | Pain | Peripheral Nervous System Diseases
-
The University of Texas Health Science Center at...CompletedNeuropathic Pain | Spinal Cord InjuriesUnited States
-
Samyang Biopharmaceuticals CorporationCompletedPostherpetic Neuralgia | Peripheral Nerve InjuryKorea, Republic of
-
University of FloridaCompletedPain | FibromyalgiaUnited States
-
Nantes University HospitalRecruitingNeuropathic Pain | Coccyx Disorder | CoccygodyniaFrance
-
Aalborg UniversityEuropean Commission; Danish National Research FoundationCompletedProlonged Pain, EEG, Resting State Functional ConnectivityDenmark
-
Kyunghee University Medical CenterUnknown
-
Aalborg UniversityRecruiting
-
Medical University of ViennaAstellas Pharma GmbHCompleted
-
NeurogesXCompletedPain | Peripheral Nervous System Diseases | Neuralgia | Herpes Zoster | ShinglesUnited States