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Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Vienna, , A-1090 Austria
Contact
1-800-718-1021
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

- Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and
dynamic mechanical allodynia to brush stimuli.

- A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain
and brush-evoked allodynia at the skin area at screen.

- Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to
the start of study.

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

- Patients who have undergone neurolytic or neurosurgical therapy.

- Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions,
multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome
(Type I and II), and phantom limb pain.

- Patients who have previously been treated with pregabalin.

NCT01117766
Pfizer
Completed
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

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Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo
Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.
Methodology to assess reproducibility and sensitivity of quantitative sensory testing
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Neuropathic Pain
  • Drug: Pregabalin
    Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients
  • Drug: Placebo
    BID dosing for 28 days
  • Active Comparator: Active drug
    Intervention: Drug: Pregabalin
  • 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
31
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
  • A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
  • Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.

Exclusion Criteria:

  • Patients who have undergone neurolytic or neurosurgical therapy.
  • Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
  • Patients who have previously been treated with pregabalin.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   United Kingdom
 
 
NCT01117766
A9011015
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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