Clinical trial NCT00352651 (phase 2, status: terminated)
Conditions: herpes zoster, postherpetic neuralgia
ICD codes: B02.39, B02.22
Drugs: pregabalin
SMILES: NCC1(CC(O)=O)CCCCC1
Reason 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
  
Eligibility 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.