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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00424372

Purpose

To evaluate the safety of the long-term use of pregabalin.

Condition	Intervention	Phase
Neuralgia, Postherpetic	Drug: pregabalin	Phase III

MedlinePlus related topics: Shingles

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In The Treatment Of Postherpetic Neuralgia

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety (the nature, frequency and intensity of adverse events and laboratory abnormalities) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Short-Form McGill Pain Questionnaire the efficacy of Change [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	126
Study Start Date:	January 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424372

Locations

Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Saitama, Japan
Japan, Aichi
Pfizer Investigational Site
Nagoya, Aichi, Japan
Japan, Chiba
Pfizer Investigational Site
Urayasu, Chiba, Japan
Japan, Fukuoka
Pfizer Investigational Site
Kasuya-gun, Fukuoka, Japan
Japan, Gunma
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Japan, Hokkaido
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Japan, Hyogo
Pfizer Investigational Site
Amagasaki, Hyogo, Japan
Pfizer Investigational Site
Himeji, Hyogo, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Akashi, Hyogo, Japan
Japan, Kanagawa
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Japan, Miyagi
Pfizer Investigational Site
Sendai, Miyagi, Japan
Japan, Ohita
Pfizer Investigational Site
Beppu, Ohita, Japan
Japan, Saitama
Pfizer Investigational Site
Kawaguchi, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Japan, Tokyo
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Mitaka, Tokyo, Japan
Pfizer Investigational Site
Arakawa-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081121
Study First Received:	January 18, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00424372
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Pregabalin
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009