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

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NCT01474772

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Dedicated Clinical Research
Goodyear, Arizona, 85395 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men or women who are at least 18 years old.

- Diagnosis of painful diabetic peripheral neuropathy.

- Pain on walking.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Inability to walk 50 feet on a flat surface.

- Pain on walking due to conditions other than diabetic peripheral neuropathy.

NCT01474772
Pfizer
Completed
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

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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, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
 
Completed
217
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   South Africa,   Sweden,   United States
 
 
NCT01474772
A0081269
2011-003266-32 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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