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To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 6, 2005
Last updated: December 28, 2006
Last verified: December 2006
To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.

Condition Intervention Phase
Diabetic Neuropathy, Painful
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Efficacy

Estimated Enrollment: 384
Study Start Date: January 2001
Estimated Study Completion Date: July 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy
  • Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

  • Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00150423

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00150423     History of Changes
Other Study ID Numbers: 1008-165 
Study First Received: September 6, 2005
Last Updated: December 28, 2006
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on October 21, 2016