Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
NCT01701362
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
- Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
- Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.
- Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post
herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome
(CTS) or with central neuropathic pain (for example, due to spinal cord injury) or
with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
- Subjects with other pain that may confound assessment or self-evaluation of the
peripheral neuropathic pain.
- Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate
course of therapy at doses greater than or equal to 150 mg/day, who have previously
participated in a pregabalin clinical trial or who have been treated with pregabalin
at any time during the 6 month period prior to screening.
- Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV
infection; any clinically unstable cardiovascular (including a myocardial infarction
[heart attack] in the 3 months prior to screening), hematological, autoimmune,
endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3
months prior to screening) respiratory, or gastrointestinal disease; symptomatic
peripheral vascular disease including intermittent claudication; uncontrolled diabetes
mellitus; untreated hypothyroidism.
- Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example,
schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder
(GAD) or major depression that is clinically stable.
- Subjects considered at risk of suicide or self-harm based on investigator judgment
and/or details of a risk assessment.
- Use of prohibited medications in the absence of appropriate washout periods.
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Descriptive Information | ||||
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Brief Title ICMJE | Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain | |||
Official Title ICMJE | A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain | |||
Brief Summary | This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Neuropathic Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21. | |||
* 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 | 542 | |||
Original Estimated Enrollment ICMJE | 470 | |||
Actual Study Completion Date ICMJE | August 2015 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Bulgaria, Canada, Croatia, Denmark, Germany, Hungary, Korea, Republic of, Poland, Puerto Rico, Romania, South Africa, Sweden, United States | |||
Removed Location Countries | Israel | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01701362 | |||
Other Study ID Numbers ICMJE | A0081279 2012-003304-12 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |