Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy - Full Text View

Purpose

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

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

MedlinePlus related topics:

Diabetic Nerve Problems Peripheral Nerve Disorders

ChemIDplus related topics:

Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Official Title:	Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

Further study details as provided by Pfizer:

Primary Outcome Measures:

Numerical rating scale for pain [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression of Change [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Short Form 36-item (SF-36) Health Survey [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Daily Sleep Interference Diary [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Short-form McGill Pain Questionnaire [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study (MOS) - Sleep Scale for sleep [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Change [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	308
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: placebo Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Pregabalin 300 mg/day: Experimental	Drug: pregabalin Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Pregabalin 600 mg/day: Experimental	Drug: pregabalin Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Eligibility

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

Criteria

Inclusion Criteria:

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

Malignancy within the past 2 years.
Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553475

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 53 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:	A0081163
First Received:	November 2, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00553475
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 October 07, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00553475