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Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

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NCT00219544

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1 Canada
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.
Neuropathic Pain
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

- Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused
by a lesion of the peripheral nervous system manifesting with sensory symptoms and
signs, for at least 6 months at screening.

- At baseline, subjects must have completed at least 4 daily pain diaries and must have
a mean weekly pain score equal or greater than 4.

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

- Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy;
Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other
entrapment-related neuropathic pain (defined as pain associated with focal nerve
lesion produced by constriction or mechanical distortion of the nerve, within a
fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain
syndrome (type 1 and 2); Fibromyalgia.

NCT00219544
Pfizer
Completed
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Neuropathic Pain
  • Drug: Pregabalin (Lyrica)
    pregabalin 150mg/day (75mg BID)
  • Drug: Pregabalin (Lyrica)
    pregabalin 300 mg/day (150mg BID)
  • Drug: Pregabalin (Lyrica)
    pregabalin 600/day (300mg BID)
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Pregabalin (Lyrica)
  • Experimental: 2
    Intervention: Drug: Pregabalin (Lyrica)
  • Experimental: 3
    Intervention: Drug: Pregabalin (Lyrica)
  • Placebo Comparator: 4
    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
158
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
  • At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria:

  • Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00219544
A0081084
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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