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

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. Identifier: NCT00159666
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 11, 2008
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Brief Summary:
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Condition or disease Intervention/treatment Phase
Post-Herpetic Neuralgia Drug: pregabalin Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin

Primary Outcome Measures :
  1. Onset meaningful pain reduction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00159666

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00159666     History of Changes
Other Study ID Numbers: A0081004
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: November 2006

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