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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Pfizer
• Treatments: Pregabalin

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.