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TerminatedNCT00352651Updated Apr 14, 2011

Study to Find Out if Therapy With the Drug Pregabalin Relieves Pain During Shingles Compared With Placebo

A Phase 2 interventional study of Pregabalin in Herpes Zoster and Postherpetic Neuralgia, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-14.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Why this study was terminated
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
Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Herpes Zoster
  • Postherpetic Neuralgia

Keywords

  • Acute Herpes Zoster (AHZ)
  • Postherpetic Neuralgia (PHN)
  • Pregabalin
  • Lyrica
  • Pain
03

In context

Herpes Zoster

370 studies on the registry are indexed under Herpes Zoster; 63 are open to participants now.

This study's planned enrollment of 34 is below the median of 242 across 306 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.

Browse University of California, San Francisco studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
34 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Subjects' pain ratings using the visual analog scale (VAS) (0-100 mm) from pre-drug through 6 hours post-drug

Secondary outcomes

  1. 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)

07

Study locations

1 site
  • UCSF Pain Clinical Research Center
    San Francisco, California 94115, United States
08

References and documents

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. doi: 10.1186/1745-6215-12-55. PubMed 21356040 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006, a primary completion of Dec 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2006
First posted
Jul 14, 2006
Start
Jun 2006
Primary completionActual
Dec 2006
CompletionActual
Dec 2006
Last update
Apr 14, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00352651
Lead sponsor
University of California, San Francisco
Collaborators
Pfizer
First posted
Jul 14, 2006
Start date
Jun 2006
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Apr 14, 2011

Study contacts

Karin L. Petersen, MD
principal investigator · University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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