Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

NCT01701362

Last updated date
Study Location
Tennesse Valley Pain Consultants
Huntsville, Alabama, 35801, United States
Contact
1-800-718-1021

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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 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.

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


- 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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Advanced Information
Descriptive Information
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
  • Drug: pregabalin
    capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
    Other Name: Lyrica, PD-144723
  • Drug: placebo
    capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
Study Arms  ICMJE
  • Active Comparator: pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
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
 (submitted: May 4, 2017)
542
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2012)
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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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