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Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

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NCT01455415

Last updated on May 9, 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]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful 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

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

- 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

NCT01455415
Pfizer
Completed
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
December 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
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,   Italy,   Sweden,   United States
 
 
NCT01455415
A0081268
2011-002743-10 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

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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