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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01701362
First received: October 3, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to Week 15 (endpoint) mean pain score. [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 470
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pregabalin Drug: pregabalin
capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
Other Name: Lyrica, PD-144723
Placebo Comparator: placebo Drug: placebo
capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701362

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 172 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01701362     History of Changes
Other Study ID Numbers: A0081279, 2012-003304-12
Study First Received: October 3, 2012
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
post-traumatic peripheral neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014