Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
WithdrawnPhase 4NCT01298466
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population
- Conditions
- Interventions
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Organization
- Pfizer
- Start date
- 2012-02
- Primary completion
- 2013-02
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01298466