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Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

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NCT01057693

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Greystone Medical Research, LLC
Birmingham, Alabama, 35242 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.
Painful Diabetic 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

- Patients must have painful diabetic peripheral neuropathy and be receiving treatment
for this condition.

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

- Patients with other pain conditions cannot participate.

NCT01057693
Pfizer
Completed
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

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Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
  • Drug: pregabalin (Lyrica)
    Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
  • Drug: Placebo
    Placebo is supplied as capsules and given 3 times daily.
  • Experimental: pregabalin (Lyrica)
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: 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
665
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

  • Patients with other pain conditions cannot participate.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   South Africa,   United States
 
 
NCT01057693
A0081242
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

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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