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A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT00424372
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : September 28, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To evaluate the safety of the long-term use of pregabalin.

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: pregabalin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In The Treatment Of Postherpetic Neuralgia
Study Start Date : January 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
Experimental: pregabalin Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Summary of Adverse Events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score [ Time Frame: 52 weeks ]
  2. Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score [ Time Frame: 52 weeks ]
  3. Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score [ Time Frame: 52 weeks ]
  4. Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity [ Time Frame: 52 weeks ]
  5. Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
  • Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

  • Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
  • Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00424372


Locations
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Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Kasuya-gun, Fukuoka, Japan
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Akashi, Hyogo, Japan
Pfizer Investigational Site
Amagasaki, Hyogo, Japan
Pfizer Investigational Site
Himeji, Hyogo, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Beppu, Ohita, Japan
Pfizer Investigational Site
Kawaguchi, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
Arakawa-ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Mitaka, Tokyo, Japan
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Saitama, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00424372     History of Changes
Other Study ID Numbers: A0081121
First Posted: January 19, 2007    Key Record Dates
Results First Posted: September 28, 2009
Last Update Posted: November 11, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs