A Randomised Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects with Neuropathic Pain Associated with Lumbo-sacral Radiculopathy
- Conditions
- Pain associated with lumbo-sacral radiculopathyMedDRA version: 7.0Level: VTcClassification code 10050085
- Registration Number
- EUCTR2004-002948-10-DE
- Lead Sponsor
- Pfizer Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 774
1. Male or female outpatients between 18 and 100 years of age.
2. Females of childbearing potential must have a negative serum b-HCG pregnancy test and be practising an effective form of contraception. Women who have been surgically sterilised or are at least two years post-menopause do not have to use contraception.
3. Pain consistent with a diagnosis of lumbosacral radiculopathy due to spinal stenosis or disk herniation. The pain must radiate to the calf or foot in manner consistent with L5 or S1 nerve root involvement. If the patient is experiencing pain in both the lower back and the calf or foot, the pain intensity in the calf or foot must be greater than that in the lower back. In addition, to ensure that patients entered into the study indeed have neuropathic pain due to L5 or S1 nerve root involvement, the subject’s pain must be co-localised with areas of sensory changes or muscle weakness.
4. The radicular pain must be present for at least 3 months and the subject’s pain must be stable for at least 4 weeks.
5. Subjects must complete the Daily Pain Rating Scale in the subject diary at least 75% of the time during screening and must have a mean weekly pain score of =4 (visit 2).
6. Subjects must be in generally good health, except for the presence of lumbo-sacral radiculopathy, based on physical examination and medical history. Other deviations must be determined as clinically insignificant by the investigator after discussion with Pfizer.
7. Screening laboratory values must be within normal limits or abnormalities must be clinically insignificant in the judgment of the investigator.
8. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry.
9. Subject is willing and able to comply with trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or lactating women or women of childbearing potential not using acceptable method of contraception.
2. Pending civil litigation or disability claims pertinent to the subject’s lumbo-sacral radiculopathy, current involvement in out-of-court settlements for claims pertinent to the subject’s lumbo-sacral radiculopathy or currently receiving monetary compensation as a result of any of the above.
3. Surgery for lumbosacral radiculopathy within the previous 6 months.
4. More than one previous spinal surgery for pain/radiculopathy in the L5-S1 distribution. Subjects who have had one or more spinal surgeries for pain/radiculopathy outside of L5-S1 distribubution may be allowed to enter the study.
5. Epidural injection for lumbo-sacral radiculopathy within the previous 6 weeks.
6. Anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic anti-depressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
7. Presence of neuropathic pain due to lumbo-sacral radiculopathy for more than 4 years.
8. Neurologic disorders unrelated to lumbo-sacral radiculopathy that may confuse or confound the assessment of neuropathic pain due to lumbo-sacral radiculopathy. (eg primary or secondary nerve diseases) including but not limited to the following:
familial neuropathies; toxic or pharmacologically induced neuropathies; infection related neuropathies; metabolic abnormalities; vascular, inflammatory, malignancy-mediated and immune-mediated neuropathies; spinal cord tumours; any progressive neurological disorder.
9. Presence of any severe pain associated with conditions other than lumbo-sacral radiculopathy that may confound the assessment or self-evaluation of the pain.
10. Any clinically significant or unstable medical or psychiatric condition or laboratory abnormality that would compromise participation in the study, such as:
significant renal disease; significant hepatic disorder; significant respiratory disorder; significant haematological disorders; significant immunological diseases; unstable cardiovascular disease; significant inflammatory or rheumatological disease; active Hepatitis B or C, HIV infection or any other significant infectious condition diagnosed within the past 3 months; symptomatic peripheral vascular disease; untreated endocrine disorders; creatinine clearance < 60 mL/min; total white blood cell count < 2500/mm3; platelet count < 100 x103/mm3.
11. Clinically significant abnormal 12-lead ECG.
12. Malignancy within the past 2 years, with the exception of basal cell carcinoma.
13. Likelihood of requiring surgery during the course of the study.
14. History of Substance Abuse as described by DSM-IV-TR diagnostic criteria.
15. Participation in any previous clinical trials for pregabalin or participation in 2 or more previous clinical trials for pain related to lumbo-sacral radiculopathy.
16. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening.
17. A previous history of intolerance or hypersensitivity to pregabalin or gabapentin.
18. Any treatment with vigabatrin, hydroxychloroquine, deferoxamine, thiorizidine or any compound known to adversely affect the retina and visual field.
19. Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the pro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method