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

NCT01298466 | Withdrawn Phase 4

• 1 other identifier: A0081256
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Neuralgia

Keywords

identification; chronic; neuropathic; low back pain; primary care; pregabalin

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).

  12 weeks

Secondary Outcomes (10)

• The time to onset of 30% pain reduction (as measured by the NRS mean pain score).

  12 weeks

• The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.

  12 weeks

• The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.

  12 weeks

• The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.

  12 weeks

• The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.

  12 weeks

Study Arms (1)

Pregabalin

EXPERIMENTAL

Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.

Drug: Pregabalin

Interventions

Pregabalin DRUG

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.

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Low Back Pain; Neuralgia; Bronchiolitis Obliterans Syndrome

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 22, 2021

Record last verified: 2012-04