Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143156

Purpose

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Condition	Intervention	Phase
Diabetic Neuropathies	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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Secondary Outcome Measures:

End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Estimated Enrollment:	450
Study Start Date:	March 2005
Study Completion Date:	May 2007

Eligibility

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

Criteria

Inclusion Criteria:

Males or females at least 18 years of age, of any ethnic origin
Type 1 or 2 diabetes mellitus
Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143156

Show 55 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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A0081071
Study First Received:	August 31, 2005
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00143156
Health Authority:	United States: Food and Drug Administration

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 16, 2009