Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 15, 2011
Last updated: August 19, 2013
Last verified: August 2013

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: Pregabalin
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Double-Blind, Randomized Cross-Over Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reduction in Diabetic Peripheral Neuropathy (DPN) pain [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Reduction in DPN pain on walking [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate, 30% and 50% improvement in mean pain response [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory-short form [ Time Frame: 14 weks ] [ Designated as safety issue: No ]
  • Daytime activity measured by actigraphy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Walk-12 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Norfolk Quality of Life for Diabetic Neuropathy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Sleep Interference Rating Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Euro Quality of Life-5 Dimensions [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabain Drug: Pregabalin
150-300 mg/day given in 3 divided doses as capsules
Other Name: Lyrica
Placebo Comparator: Placebo Other: placebo
matching placebo capsules given in 3 divided doses


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

Inclusion Criteria:

  • Men or women who are at least 18 years old.
  • Diagnosis of painful diabetic peripheral neuropathy.
  • Pain on walking.

Exclusion Criteria:

  • Inability to walk 50 feet on a flat surface.
  • Pain on walking due to conditions other than diabetic peripheral neuropathy.
  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 ClinicalTrials.gov identifier: NCT01474772

  Show 45 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01474772     History of Changes
Other Study ID Numbers: A0081269
Study First Received: November 15, 2011
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic Peripheral Neuropathy
Pain on Walking

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014