Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352651
Status:
TERMINATED
Last Update Posted:
2011-04-14
First Post:
2006-07-12
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:
University of California San Francisco
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 300000 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None