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P4 (Pregabalin for Peripheral Posttraumatic Pain)

Last updated on December 7, 2019

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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.
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- 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.
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- 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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Descriptive Information
Brief Title  ICMJE P4 (Pregabalin for Peripheral Posttraumatic Pain)
Official Title  ICMJE A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Brief SummaryTo evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia
Intervention  ICMJE
  • Drug: pregabalin
    pregabalin
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2011)
255
Original Enrollment  ICMJE
 (submitted: February 13, 2006)
260
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion DateMay 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Denmark,   Finland,   Italy,   Netherlands,   Portugal,   Romania,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00292188
Other Study ID Numbers  ICMJE A0081064
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

ICMJE     Data element required by the

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

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