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

NCT00352651 | Terminated Phase 2

• 1 other identifier: H11609-27650
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster; Postherpetic Neuralgia

Keywords

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

Outcome Measures

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)

Interventions

Pregabalin DRUG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Pfizer: collaborator

Study Sites (1)

UCSF Pain Clinical Research Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 21356040 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Karin L. Petersen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 14, 2011

Record last verified: 2011-03

Locations

US (1)