Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 8, 2005
Last updated: March 7, 2008
Last verified: November 2006
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Condition Intervention Phase
Post-Herpetic Neuralgia
Drug: pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Onset meaningful pain reduction

Estimated Enrollment: 255
Study Start Date: October 2004
Estimated Study Completion Date: June 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
  • Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion Criteria:

  • History of neurolytic or neurosurgical therapy for PHN.
  • Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00159666

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00159666     History of Changes
Other Study ID Numbers: A0081004 
Study First Received: September 8, 2005
Last Updated: March 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Anti-Anxiety Agents
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents processed this record on May 26, 2016