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Herpes ZosterPhase 2NCT00352651

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

A Phase 2 study testing Pregabalin in people with Herpes Zoster and Postherpetic Neuralgia, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Herpes Zoster, Postherpetic Neuralgia
What is being tested?
Pregabalin
How many people
34 participants
Where
1 siteUnited States
Study dates
Jun 2006to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female 21 years of age or older
  • 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.
  • Subjects must have had pain present for more than 3 days but less than 42 days after onset of the herpes zoster skin rash.
  • 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.
  • Subjects must weigh more than 110 pounds and have a body mass index greater than or equal to 20.
  • No medications for AHZ pain other than nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen and opioids; maintained at a stable dose throughout the study.
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  • 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.
  • Ability to understand and follow the instructions of the investigator, including completion of the study diaries as described in the protocol.
  • Ability to provide informed written consent.

Who cannot join

  • The AHZ outbreak is complicated by stroke or myelopathy.
  • Patients with signs of spinal cord or brainstem injury from HZ.
  • Subjects who have demonstrated a hypersensitivity to pregabalin (or gabapentin) or who have been previously treated with either.
  • Subjects who have undergone neurolytic or neurosurgical therapy for AHZ.
  • Subjects treated with local anesthetic nerve blocks within 48 hours of study entry.
  • Subjects with a creatinine clearance of 60 mL/minute or less or significant renal disease as determined by study physician.
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  • Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
  • Subjects having other severe pain that may confound assessment of the AHZ pain.
  • 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).
  • 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.
  • Pregnant or lactating women.
  • Subjects who are currently taking anticonvulsants.
  • Subjects who have a history of illicit drug or alcohol abuse within the last year.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Pain Clinical Research Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Placebo-Controlled Study of Pregabalin for the Pain of Acute Herpes Zoster

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.

Being tested
Pregabalin
Keywords
Acute Herpes Zoster (AHZ), Postherpetic Neuralgia (PHN), Pregabalin, Lyrica, Pain
Medical subject headings
Herpes Zoster, Neuralgia, Postherpetic, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2006
  4. Study completionDec 2006

Why it stopped: 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352651
Sponsor's protocol ID
H11609-27650
Status last verified
Mar 2011
First submitted
12 Jul 2006
Last updated
14 Apr 2011
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pregabalin in people with Herpes Zoster and Postherpetic Neuralgia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects' pain ratings using the visual analog scale (VAS) (0-100 mm) from pre-drug through 6 hours post-drug. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00352651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.

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