Study to Find Out if Therapy With the Drug Pregabalin Relieves Pain During Shingles Compared With Placebo
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
)Tracking Information | |||||
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First Received Date ICMJE | July 12, 2006 | ||||
Last Updated Date | April 12, 2011 | ||||
Start Date ICMJE | June 2006 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Subjects' pain ratings using the visual analog scale (VAS) (0-100 mm) from pre-drug through 6 hours post-drug | ||||
Original Primary Outcome Measures ICMJE |
Subjects’ pain ratings using the Visual Analog Scale (VAS) (0-100 mm) from pre-drug through 6 hours post-drug. | ||||
Change History | Complete list of historical versions of study NCT00352651 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Subject ratings of allodynia severity to 3 strokes with a foam brush, the surface areas of greatest pain and allodynia, side effect scores, and a Category Pain Relief Scale rating from 0 (pain worsened) to 5 (complete pain relief) | ||||
Original Secondary Outcome Measures ICMJE |
Subject ratings of allodynia severity to 3 strokes with a foam brush, the surface areas of greatest pain and allodynia, side effects scores, and a Category Pain Relief Scale rating from 0 (pain worsened) to 5 (complete pain relief). | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Find Out if Therapy With the Drug Pregabalin Relieves Pain During Shingles Compared With Placebo | ||||
Official Title ICMJE | Placebo-Controlled Study of Pregabalin for the Pain of Acute Herpes Zoster | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Pregabalin | ||||
Study Arm (s) | |||||
Publications * | Jensen-Dahm C, Rowbotham MC, Reda H, Petersen KL. Effect of a single dose of pregabalin on herpes zoster pain. Trials. 2011 Feb 28;12:55. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Estimated Enrollment ICMJE | 34 | ||||
Completion Date | December 2006 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 80 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352651 | ||||
Other Study ID Numbers ICMJE | H11609-27650 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Michael Rowbotham, University of California, San Francisco | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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Information Provided By | University of California, San Francisco | ||||
Verification Date | March 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |