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Trial record 1 of 1 for:    NCT01202227
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An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01202227
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2010
First Posted Date  ICMJE September 15, 2010
Results First Submitted Date  ICMJE January 10, 2013
Results First Posted Date  ICMJE May 17, 2013
Last Update Posted Date May 17, 2013
Study Start Date  ICMJE September 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • Number of Participants With Peripheral Edema [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
  • Number of Participants With Facial/Periorbital Edema [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    Number of participants who had facial or periorbital edema.
  • Number of Participants With Generalized or Abdominal Edema [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    Number of participants who had generalized or abdominal edema.
  • Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT) [ Time Frame: Baseline, Weeks 4, 20, 36, 52, and 53 ]
    DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
  • Number of Participants With Visual Field Deteriorated [ Time Frame: 53 weeks ]
    Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
  • Number of Participants With Deterioration in Neurological Examination Findings [ Time Frame: 53 weeks ]
    Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
  • Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • Adverse events [ Time Frame: At multiple timepoints during study period from Week 0 to 53 ]
  • Weight, blood pressure, pulse rate, physical exams [ Time Frame: Week 4, 8, 12, 20, 28, 36, 44, 52, 53 ]
  • Edema assessments, DVT assessments [ Time Frame: Week 4, 20, 36, 52, 53 ]
  • Ophthalmologic exams (Week 20, and 52 or 53) ,neurological exams, 12-lead ECG [ Time Frame: Week 52 or 53 ]
  • Clinical laboratory testing (hematology, blood chemistry, urinalysis) [ Time Frame: Week 4, 12, 20, 36, and 52 or 53 ]
Change History Complete list of historical versions of study NCT01202227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement.
  • Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement.
  • Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement.
  • Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score [ Time Frame: Baseline, Week 52 ]
    The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale. Change = observation mean at Week 52 minus baseline mean.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • The Short-Form McGill Pain Questionnaire [ Time Frame: Week 0,2,4,8,12,20,28,36,44,52 ]
  • The modified Brief Pain Inventory Interference Scale 10-items (mBPI-10) score [ Time Frame: Week 1 and 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Official Title  ICMJE An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)
Brief Summary The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Neuralgia
  • Pain
Intervention  ICMJE Drug: pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Study Arms  ICMJE Experimental: Pregabalin
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
Intervention: Drug: pregabalin
Publications * Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.

*   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 17, 2012)
104
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2010)
100
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria for subjects to be shifted from Study A0081107

  • Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
  • Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);

Inclusion criteria for subjects to be new participants in this study

  • Subjects with central neuropathic pain after stroke or multiple sclerosis;
  • At least 6 months have passed after the onset of central neuropathic pain;
  • Pain VAS at least 40mm in Visit 1 and Visit 2;

Exclusion Criteria:

  • Creatinine clearance < 60 mL/min;
  • Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;
  • Subjects who are expected to require surgery during the trial;
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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01202227
Other Study ID Numbers  ICMJE A0081252
Has Data Monitoring Committee No
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 Center Pfizer
PRS Account Pfizer
Verification Date April 2013

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