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(protocol dates 2004-11-16 and 2004-11-15)

Pfizer AB0 sites774 target enrollmentMarch 4, 2005

ConditionsPain associated with lumbo-sacral radiculopathy MedDRA version: 7.0Level: VTcClassification code 10050085

DrugsLyrica

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pain associated with lumbo-sacral radiculopathy
Sponsor: Pfizer AB
Enrollment: 774
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 4, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer AB

Eligibility Criteria

Inclusion Criteria

•Male or female outpatients between 18 and 100 years of age.
•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.
•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 subjects pain must be co\-localised with areas of sensory changes or muscle weakness.
•The radicular pan must be present for at least 3 months and the subject’s pain must be stable for at least 4 weeks
•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\).
•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.
•Screening laboratory values must be within normal limits or abnormalities must be clinically insignificant in the judgment of the investigator.
•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.
•Subject is willing and able to comply with trial procedures.
•Are the trial subjects under 18? no

Exclusion Criteria

•Pregnant or lactating women or women of childbearing potential not using acceptable method of contraception.
•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
•Surgery for lumbosacral radiculopathy within the previous 6 months.
•More than one previous spinal surgery for pain/radiculopathy in the L5\-S1 distribution
•Epidural injection for lumbo\-sacral radiculopathy within the previous 6 weeks.
•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
•Presence of neuropathic pain due to lumbo\-sacral radiculopathy for more than 4 years
•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.
•Presence of any severe pain associated with conditions other than lumbo\-sacral radiculopathy that may confound the assessment or self\-evaluation of the pain
•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\.