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View Clinical Trial (Medical Research Study)
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Study to Find Out if Therapy With the Drug Pregabalin Relieves Pain During Shingles Compared With Placebo - NCT00352651-94115 (Clinical Trial 146651)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy146651.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94115 |
| Conditions: |
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Herpes Zoster - Postherpetic Neuralgia |
| Purpose: |
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The purpose of this study is to see if therapy with the drug pregabalin relieves pain during
shingles compared with placebo. A placebo is an inactive substance. Pregabalin is a drug
marketed as Lyrica™ in the United States for the treatment of seizures, diabetic neuropathy,
and post-herpetic neuralgia. The use of pregabalin and drugs like it for the treatment of
pain during the acute phase of shingles is experimental. Thirty four subjects will complete
the study at the University of California, San Francisco (UCSF) Pain Clinical Research
Center. This study is funded by Pfizer Global Research.
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| Study summary: |
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The varicella zoster virus (VZV) is the smallest of the double-stranded DNA herpes viruses,
and the only one capable of producing two different diseases, varicella (chickenpox) and
herpes zoster (acute herpes zoster [AHZ], shingles). The incidence of AHZ, and the
secondary VZV infection, is strongly age-dependent and reaches 1% per year by age 80 and
there are between 300,000 and 1 million new cases of AHZ each year in the US. AHZ is almost
always painful, and the pain can be of disabling severity, rendering some sufferers
bed-bound and too incapacitated to carry out normal activities, leading to weight loss and
dehydration sufficient to require inpatient therapy. The elderly are especially likely to
suffer severe pain.
The most common complication of AHZ is development of postherpetic neuralgia (PHN). Although
the overall incidence of PHN after AHZ is about 10%, the incidence has been reported to rise
as high as 80% in those over the age of 80. In all published studies, age and greater
severity of initial zoster pain are each found to significantly increase the risk of
developing PHN. Severe zoster pain is believed to correlate with a more severe cutaneous
outbreak, more severe inflammation of the nerve trunk, and possibly greater injury to
primary afferent nerve fibers.
There are two separate issues to address when discussing the pain of AHZ. The first is
managing the AHZ pain itself, because the burden of suffering is so high. The second is
reducing the incidence of PHN. Both issues need to be considered in trial design, in part
because severe AHZ pain is itself a risk factor for PHN. Studies of the analgesic effect of
pregabalin suggest an analgesic profile similar to that of gabapentin. We would therefore
predict, that pregabalin would reduce the pain associated with AHZ and possibly prevent
development of PHN. |
| Criteria: |
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Inclusion Criteria:
1. Male or female 21 years of age or older
2. Subjects must have an acute outbreak of herpes zoster (HZ) with unilateral skin rash
and pain; the diagnosis will be based on physical examination and review of available
medical records confirming the outbreak.
3. Subjects must have had pain present for more than 3 days but less than 42 days after
onset of the herpes zoster skin rash.
4. Subjects at screening must have an average score of at least 40 mm on the visual
analog scale (VAS) of the SF-McGill Pain Questionnaire.
5. Subjects must weigh more than 110 pounds and have a body mass index greater than or
equal to 20.
6. No medications for AHZ pain other than nonsteroidal anti-inflammatory drugs (NSAIDs),
acetaminophen and opioids; maintained at a stable dose throughout the study.
7. No use of topical medications less than 12 hours prior to each study medication
visit. No use of NSAIDs, acetaminophen, or opioids less than 2 hours prior to each
study medication visit.
8. Ability to understand and follow the instructions of the investigator, including
completion of the study diaries as described in the protocol.
9. Ability to provide informed written consent.
Exclusion Criteria:
1. The AHZ outbreak is complicated by stroke or myelopathy.
2. Patients with signs of spinal cord or brainstem injury from HZ.
3. Subjects who have demonstrated a hypersensitivity to pregabalin (or gabapentin) or
who have been previously treated with either.
4. Subjects who have undergone neurolytic or neurosurgical therapy for AHZ.
5. Subjects treated with local anesthetic nerve blocks within 48 hours of study entry.
6. Subjects with a creatinine clearance of 60 mL/minute or less or significant renal
disease as determined by study physician.
7. Clinically significant hepatic, respiratory, hematological, cardiovascular or
neurological disease.
8. Subjects having other severe pain that may confound assessment of the AHZ pain.
9. Subjects who have serious, unstable, or clinically significant medical or
psychological conditions, which, in the opinion of the investigator(s), would
compromise the subject's participation in the study (including clinically significant
dehydration or unstable vital signs).
10. Subjects taking or having taken any other experimental drugs, drugs not approved in
the United States, or participating in or having participated in other clinical
studies in the 30 days prior to this clinical trial.
11. Pregnant or lactating women.
12. Subjects who are currently taking anticonvulsants.
13. Subjects who have a history of illicit drug or alcohol abuse within the last year.
14. Subjects who are considered unreliable as to medication compliance or adherence to
scheduled appointments, or for other reasons are felt to be inappropriate for
inclusion in the study as determined by the investigators. |
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| Study is available at: |
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UCSF Pain Clinical Research Center
San Francisco, CA 94115
United States
Primary Contact:
Marlene Berro, MS
Phone: 415-885-7812 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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