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Efficacy of Pregabalin in Patients With Radicular Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908375
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : September 16, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
kahlid malik, Northwestern University

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 25, 2009
Results First Submitted Date  ICMJE May 29, 2014
Results First Posted Date  ICMJE September 16, 2014
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
Pain Scores (NRS) at 3-weeks [ Time Frame: 3 weeks ]
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
Overall change in pain scores [ Time Frame: 3 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Patient's Global Impression of Change at 3 Weeks [ Time Frame: 3 weeks ]
    Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:
    1. Very Much Improved
    2. Much Improved
    3. Minimally Improved
    4. No Change
    5. Minimally Worse
    6. Much Worse
    7. Very Much Worse
  • Oswestry Disability Questionnaires [ Time Frame: 3 weeks ]
    Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Global impression of change in patient status [ Time Frame: 3 weeks ]
  • Oswestry and Roland-Morris disability questionnaires [ Time Frame: 3 weeks ]
  • Standard morphine equivalents of analgesic medications used [ Time Frame: 3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pregabalin in Patients With Radicular Pain
Official Title  ICMJE Efficacy of Pregabalin in Patients With Radicular Pain
Brief Summary The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
Detailed Description Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathy; Radicular, Lumbar, Lumbosacral
  • Failed Back Surgery Syndrome
  • Spinal Stenosis
  • Herniated Disc
Intervention  ICMJE
  • Drug: Pregabalin
    One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
    Other Name: Lyrica®, Pfizer NY, NY 10017
  • Drug: Sugar Pill
    One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Pregabalin
    A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Surgar Pill
    One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
    Intervention: Drug: Sugar Pill
Publications * Not Provided

*   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: February 5, 2014)
39
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
38
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with pain in dermatomal distribution, in either cervical or lumbar region.
  2. History of pain for more than 3 months.
  3. History of herniated disc, spinal stenosis or failed back surgery.
  4. A series of epidural steroid injections within the past 6 months.
  5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
  6. Patients must be cognitively capable of completing the pain questionnaires.

Exclusion Criteria:

  1. Patients below 18 or over 65 years of age.
  2. Patients with mostly axial spinal pain.
  3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
  4. Workmen's compensation or disability issues.
  5. Patients with chronic depression and on depression medications.
  6. Addiction and/or substance abuse issues.
  7. Patients using gabapentin or failure to respond to previous gabapentin use.
  8. Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
  9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
  10. History of angioedema with pregabalin use.
  11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
  12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
  13. Pregnant patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908375
Other Study ID Numbers  ICMJE FRA7057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party kahlid malik, Northwestern University
Original Responsible Party Khalid Malik, M.D., Assistant Professor of Anesthesiology, Northwestern University, Feinberg School of Medicine
Current Study Sponsor  ICMJE Northwestern University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Khalid M Malik, MD Northwestern University
PRS Account Northwestern University
Verification Date September 2014

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