Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Post-Herpetic, (HIV,Chemotherapy) Diabetic Induced - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00407511

Purpose

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Condition	Intervention	Phase
Neuralgia, Post-Herpetic Diabetic Neuropathic Pain HIV Related Peripheral Neuropathic Pain Chemotherapy Induced Peripheral Neuropathic Pain	Drug: Pregabalin	Phase IV

MedlinePlus related topics: AIDS Peripheral Nerve Disorders Shingles

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain

Further study details as provided by Pfizer:

Primary Outcome Measures:

Changing from baseline to week 12/early termination in the weekly mean pain score from the daily pain rating scale (DPRS) [ Time Frame: week 12/early termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Global Impression of Change (PGIC) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (CGIC) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory-Short Form (m-BPI.sf) at Week 0, 8 and 12 [ Time Frame: Week 0, 8 and 12 ] [ Designated as safety issue: No ]
Pain Treatment Satisfaction Scale (PTSS) at week 0, 8 and 12 [ Time Frame: Week 0, 8 and 12 ] [ Designated as safety issue: No ]
Visual Analogue Scale for Pain (VAS-pain) from week 0 to 12 [ Time Frame: Week 0 to 12 ] [ Designated as safety issue: No ]
Global Anxiety Visual Analogue Scale (GA-VAS) at week 0, 8 and 12 [ Time Frame: Week 0, 8 and 12 ] [ Designated as safety issue: No ]
Daily Sleep Interference Score from week 0 to 12 [ Time Frame: Week 0 to 12 ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	March 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pregabalin: No Intervention	Drug: Pregabalin Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).

Eligibility

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

Criteria

Inclusion Criteria:

Patients who are diagnosed of neuropathic pain associates with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Exclusion Criteria:

Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407511

Locations

Colombia, Cundinamarca
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Ecuador, Pichincha
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Mexico, B. C.
Pfizer Investigational Site
Tijuana, B. C., Mexico, 22010
Mexico, B.C.
Pfizer Investigational Site
Mexicali, B.C., Mexico, 21100
Mexico, Distrito Federal
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 14080
Mexico, Guerrero
Pfizer Investigational Site
Acapulco, Guerrero, Mexico, 39670
Mexico, Monterrey, NL
Pfizer Investigational Site
México, Monterrey, NL, Mexico, 64460
Mexico, Yucatan
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
Peru
Pfizer Investigational Site
Lima, Peru, L13
Pfizer Investigational Site
Lima, Peru, 27
Venezuela, Distrito Capital
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela, 1020

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081097
Study First Received:	December 1, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00407511
Health Authority:	Colombia: Instituto Nacional de Vigilancia de Alimentos y Medicamentos -INVIMA

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
HIV Infections

Peripheral Nervous System Diseases
Acquired Immunodeficiency Syndrome
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