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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.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455415
First received: October 17, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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

  Eligibility

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

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
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: NCT01455415

  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Pregabalin
Analgesics
Anticonvulsants
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 November 24, 2014