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Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study (PINPOINT)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298466
First received: February 16, 2011
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Neuralgia
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to onset of 30% pain reduction (as measured by the NRS mean pain score). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin
Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.
Drug: Pregabalin
The investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298466

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01298466     History of Changes
Other Study ID Numbers: A0081256
Study First Received: February 16, 2011
Last Updated: April 17, 2012
Health Authority: UNITED KINGDOM: European Medicines Agency

Keywords provided by Pfizer:
identification
chronic
neuropathic
low back pain
primary care
pregabalin

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014