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

October 17, 2011
December 19, 2013
December 2011
November 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01455415 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of NSAID For Other Pain Conditions

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Painful Diabetic Peripheral Neuropathy
  • Drug: pregabalin
    150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
  • Drug: placebo
    matching placebo 3 time a day
  • Experimental: 1: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Sweden,   Czech Republic,   Italy
 
NCT01455415
A0081268
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP