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P4 (Pregabalin for Peripheral Posttraumatic Pain)

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including
post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain,
confirmed by a qualified pain specialist and persisting for a minimum of 3 months
following the traumatic event

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

- Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome
(CRPS, Type I or Type II)

- NeP not due to trauma, and not peripheral pain

NCT00292188
Pfizer
Completed
P4 (Pregabalin for Peripheral Posttraumatic Pain)

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P4 (Pregabalin for Peripheral Posttraumatic Pain)
A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuralgia
  • Drug: pregabalin
    pregabalin
  • Drug: Placebo
    placebo
  • Experimental: Active
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion Criteria:

  • Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
  • NeP not due to trauma, and not peripheral pain
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   Finland,   Italy,   Netherlands,   Portugal,   Romania,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00292188
A0081064
No
Not Provided
Not Provided
Director, Clinical Trial 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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