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 POPULATION.
- Conditions
- ow back painlow back pain
- Registration Number
- NL-OMON36502
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 80
1. 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.
2. Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
3. 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.
4. 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).
5. Patients must be taking stable pain medication (for 30 days).
6. Patients must have failed to respond to standard analgesic therapy (eg, non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (eg, tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
7. 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).
8. 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.
1. Participation in other studies within 30 days before the current study begins and/or during study participation.
2. 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.
3. A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.
4. Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).
5. Patients who have previously taken pregabalin or gabapentin less than 6 months prior to entering the study.
6. Patients who have undergone previous surgery for back pain.
7. Patients who are using high doses of opioid medication (morphine > 60 mg per day).
8. Patients with a contraindication to receiving pregabalin as per the EU Summary of
Product Characteristics (SmPC).
9. Pregnant or lactating women, or women of childbearing potential including women less
than two years post-menopausal not using an effective method of contraception.
10. Patients scheduled to have planned or elective surgery during the course of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain<br /><br>score at the end of the study (Week 12) compared with baseline.<br /><br>2. The Patients' Global Impression of Change (PGIC) score at the end of the<br /><br>study (Week 12).</p><br>
- Secondary Outcome Measures
Name Time Method