Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352651
Recruitment Status : 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

)
First Posted : July 14, 2006
Last Update Posted : April 14, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Postherpetic Neuralgia Drug: Pregabalin Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled Study of Pregabalin for the Pain of Acute Herpes Zoster
Study Start Date : June 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin




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

Secondary Outcome Measures :
  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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352651


Locations
Layout table for location information
United States, California
UCSF Pain Clinical Research Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: Karin L. Petersen, MD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Rowbotham, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00352651     History of Changes
Other Study ID Numbers: H11609-27650
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: March 2011
Keywords provided by University of California, San Francisco:
Acute Herpes Zoster (AHZ)
Postherpetic Neuralgia (PHN)
Pregabalin
Lyrica
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs