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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01701362
First received: October 3, 2012
Last updated: March 25, 2014
Last verified: March 2014

October 3, 2012
March 25, 2014
October 2012
August 2015   (final data collection date for primary outcome measure)
Change from baseline to Week 15 (endpoint) mean pain score. [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01701362 on ClinicalTrials.gov Archive Site
  • Patient Global Impression of Pain (PGIC) [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 1 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 2 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 3 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 4 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 5 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 5 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 6 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 7 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 7 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 8 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 9 mean pain score derived from the subject's daily pain diary [ Time Frame: Basline, Week 9 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 10 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 10 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 11 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 11 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 12 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 13 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 14 mean pain score derived from the subject's daily pain diary [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 1 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 2 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 3 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 4 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 5 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 5 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 6 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 7 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 7 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 8 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 9 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 9 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 10 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 10 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 11 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 11 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 12 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 13 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 14 mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) mean sleep interference score from the subject's daily sleep diary [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) in the Medical Outcomes Study (MOS) Sleep Scale total score [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) in the Medical Outcomes Study (MOS) Sleep Scale for each domain [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) in the Pain Severity Index derived from the Brief Pain Inventory (BPI-sf) [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) in the Pain Interference Index derived from the Brief Pain Inventory (BPI-sf) [ Time Frame: Baselin, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint (Week 15) in the quality of life using the EuroQol (EQ-5D) Health State Profile scores [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Treatment response in pregabalin and placebo arms: Reduction in endpoint (Week 15) mean pain of greater than or equal to 30% [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Treatment response in pregabalin and placebo arms: Reduction in endpoint (Week 15) mean pain of greater than or equal to 50% [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Summarization of Healthcare Utilization Economic Assessment at baseline and endpoint (Week 15) [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at Week 9 [ Time Frame: Week 9 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at endpoint (Week 15) [ Time Frame: Week 15 ] [ Designated as safety issue: Yes ]
  • Neurological examination including a neuropathic pain assessment at screening [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Neurological examination at endpoint (Week 15) [ Time Frame: Week 15 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
A Double-blind, Randomized, Placebo-Controlled, Multicenter, Safety and Efficacy Study of Pregabalin in the Treatment of Patients With Post-Traumatic Peripheral Neuropathic Pain

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Neuropathic Pain
  • 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
  • Active Comparator: pregabalin
    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.
 
Recruiting
470
August 2015
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Bulgaria,   Canada,   Croatia,   Denmark,   Germany,   Hungary,   Poland,   Romania,   Sweden
 
NCT01701362
A0081279
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP