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

This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01474772
First received: November 15, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

November 15, 2011
April 29, 2013
December 2011
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01474772 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
  • Drug: Pregabalin
    150-300 mg/day given in 3 divided doses as capsules
    Other Name: Lyrica
  • Other: placebo
    matching placebo capsules given in 3 divided doses
  • Experimental: Pregabain
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
175
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Czech Republic,   South Africa,   Sweden
 
NCT01474772
A0081269
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

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