Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study

• Status: Withdrawn
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.

• Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.

• Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.

• Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).

Exclusion Criteria:

• A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.

• Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).

• Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.

• Patients who have undergone previous surgery for back pain.

• Patients who are using high doses of opioid medication (morphine > 60 mg per day).