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

NCT01474772

Last updated date
Study Location
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Pregabain
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Publications * Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
217
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2011)
175
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   South Africa,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474772
Other Study ID Numbers  ICMJE A0081269
2011-003266-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

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