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

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2010-022955-43-GR
• Date of registration: 17/05/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
• Public title: 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
• Scientific title: 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 - PINPOINT - Primary Care IdeNtification of Patients with chrOnic NeuropaThic low back pain
• Date of first enrolment: 04/07/2011
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022955-43
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Finland, France, Germany, Greece, Netherlands, Spain, Sweden, United Kingdom

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Ltd

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Ltd

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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: 13.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Lyrica®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Primary end point(s): 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.
The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).

Secondary Objective: To assess the time to achieve a clinically meaningful analgesic response with pregabalin by determining the time to onset of 30% pain reduction.
To assess the impact of treatment with pregabalin on: anxiety and depression; sleep quality; absenteeism and labour productivity; physical functioning with respect to daily activities
To assess the correlation between the observed changes in two different measures of neuropathic pain.
To note the proportion of patients treated with pregabalin with a 30% reduction in pain from baseline at study endpoint and the proportion of patients with a 50% reduction in pain over the same period.
To characterize the utility of screening tools to support the identification of patients with neuropathic chronic low back pain.
To characterize the 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.

Timepoint(s) of evaluation of this end point: 1. 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.
2. The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12)

Main Objective: To raise awareness and enhance the diagnosis of patients with chronic low back pain(CLBP) with a neuropathic pain component who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain in a primary care setting and assess the effectiveness and tolerability of pregabalin in this group of patients.
To assess patient satisfaction with treatment with pregabalin in patients with CLBP with a neuropathic pain component who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain in a primary care setting.

Secondary Outcome(s)

Secondary end point(s): 1.To assess the time to achieve a clinically meaningful analgesic response with pregabalin
by determining the time to onset of 30% pain reduction.
2.To assess the impact of treatment with pregabalin on anxiety and depression.
3.To assess the impact of treatment with pregabalin on sleep quality.
4.To assess the impact of treatment with pregabalin on absenteeism and labour
productivity.
5.To assess the impact of treatment with pregabalin on physical functioning with respect to daily activities.
6.To assess the correlation between the observed changes in two different measures of
neuropathic pain.
7.To note the proportion of patients treated with pregabalin with a 30% reduction in pain
from baseline at study endpoint and the proportion of patients with a 50% reduction in
pain over the same period.
8.To characterize the utility of screening tools to support the identification of patients with
neuropathic chronic low back pain.
9.To characterize the 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.

Timepoint(s) of evaluation of this end point: 1.Time to onset of 30% pain reduction(measured by NRS mean pain score)
2.Change in HADS score at the end of study(EOS) compared to Baseline 3.Change in Sleep Interference Scale score at the EOS compared to Baseline 4.Change in LWDE score at the EOS compared to Baseline 5.Change in RMDQ score at the EOS compared to Baseline 6.Change in PainDetect vs StEP scores at the EOS compared to Baseline
7.Proportion of patients with a 30% reduction in pain at the EOS compared to Baseline
8.Proportion of patients with a 50% reduction in pain at the EOS compared to Baseline
9.Percentage of primary care physicians who find screening tools useful to support the detection of neuropathic CLBP in daily practice
10.Nature & incidence of AEs for patients taking 150mg pregabalin at night as a single dose

Secondary ID(s)

A0081256

2010-022955-43-FI

Source(s) of Monetary Support

Pfizer Ltd