Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 17, 2011
Last updated: December 19, 2013
Last verified: December 2013

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.

Condition Intervention Phase
Painful Diabetic Peripheral Neuropathy
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of NSAID For Other Pain Conditions

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score, based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of 30% and 50% pain responders using NRS scores from the daily pain diary (Pain Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change assessed at the end of Period 1 (PGIC) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Daily Sleep Interference Rating Scale (Sleep Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Quality of life using Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QoL DN) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • European Quality of Life in 5 Dimensions (EQ 5D) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Pain severity and impact using the Brief Pain Inventory - short form (BPI sf) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Pregabalin Drug: pregabalin
150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
Placebo Comparator: 2: Placebo Drug: placebo
matching placebo 3 time a day


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

Inclusion Criteria:

  • Type 1 or 2 diabetes with painful neuropathy
  • Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
  • Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

  • History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
  • Participated in a previous or ongoing pregabalin clinical trial
  • Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455415

  Show 60 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: NCT01455415     History of Changes
Other Study ID Numbers: A0081268
Study First Received: October 17, 2011
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

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
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014