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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00908375 |
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Date of registration:
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21/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Pregabalin in Patients With Radicular Pain
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Scientific title:
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Efficacy of Pregabalin in Patients With Radicular Pain |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00908375 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Khalid M Malik, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuropathy; Radicular, Lumbar, Lumbosacral
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Spinal Stenosis
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Herniated Disc
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Failed Back Surgery Syndrome
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Intervention(s)
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Drug: Pregabalin
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Drug: Sugar Pill
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Primary Outcome(s)
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Pain Scores (NRS) at 3-weeks
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Oswestry Disability Questionnaires
[Time Frame: 3 weeks]
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Patient's Global Impression of Change at 3 Weeks
[Time Frame: 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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