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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00908375
Other study ID # FRA7057
Secondary ID
Status Completed
Phase Phase 4
First received May 21, 2009
Last updated October 2, 2014
Start date May 2009
Est. completion date December 2012

Study information

Verified date September 2014
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Pain Medicine Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scores (NRS) at 3-weeks Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. 3 weeks No
Secondary Patient's Global Impression of Change at 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:
Very Much Improved
Much Improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse
3 weeks No
Secondary Oswestry Disability Questionnaires 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. 3 weeks No
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