Clinical trial NCT01298466: Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Low Back Pain
Neuralgia
Keywords: identification
chronic
neuropathic
low back pain
primary care
pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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).

Primary outcomes:
measure: The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
timeFrame: 12 weeks
measure: The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
timeFrame: 12 weeks
Secondary outcomes:
measure: The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
timeFrame: 12 weeks
measure: The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.
timeFrame: 12 weeks
measure: The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
timeFrame: 12 weeks
measure: The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.
timeFrame: 12 weeks
measure: The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.
timeFrame: 12 weeks
measure: The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).
timeFrame: 12 weeks
measure: The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
timeFrame: 12 weeks
measure: The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
timeFrame: 12 weeks
measure: The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.
timeFrame: 12 weeks
measure: The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: