A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

This study is currently recruiting participants.

Verified by Pfizer, January 2009

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00553280

Purpose

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Condition	Intervention	Phase
Diabetic Neuropathy, Painful	Drug: pregabalin	Phase III

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of pregabalin [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (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

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

Criteria

Inclusion Criteria:

Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
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 (A0081163) 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 (A0081163)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553280

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 41 Study Locations

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:	A0081164
Study First Received:	November 2, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00553280
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

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 15, 2009