OPEN LABEL 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 POPULATIO

Conditions: Pregabalin (Lyrica ®) is approved in the European Union for the treatment of peripheral and central neuropathic pain in adults. The medical condition being investigated in this study is chronic neuropathic low back pain.
MedDRA version: 13.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-022955-43-GR

Lead Sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

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 study.
Adult patients (aged 18 years or over) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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 baseline.
Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period (based on patients having completed at least 4 daily pain diaries within the last 7 days).
Patients must be taking stable pain medication (for 30 days).
Patients must have failed to respond to standard analgesic therapy (eg, non-steroidal antiinflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (eg, tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
Female subjects of childbearing potential must not be pregnant or lactating at screening and must have a negative urine pregnancy test at screening (women post-menopausal for <2 years will also require a urine pregnancy test at screening).
Female subjects of childbearing potential must be using effective contraception since the last date of their menses and continue to do so during the study period.
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Participation in other studies within 30 days before the current study begins and/or during study participation.
Other severe acute or chronic medical condition (eg, cancer) or psychiatric condition including suicidal behaviour or active suicidal ideation) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 less than 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).
Patients with a contraindication to receiving pregabalin as per the EU Summary of
Product Characteristics (SmPC).
Pregnant or lactating women, or women of childbearing potential including women less than two years post-menopausal not using an effective method of contraception.
Patients scheduled to have planned or elective surgery during the course of the study.

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

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