Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00352651
Status:
TERMINATED
Last Update Posted:
2011-04-14
First Post:
2006-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Find Out if Therapy With the Drug Pregabalin Relieves Pain During Shingles Compared With Placebo
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Placebo-Controlled Study of Pregabalin for the Pain of Acute Herpes Zoster
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study should be terminated as the study has been closed for years and the investigator has since retired. No records are available.
Thank you, Marlene
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: