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

NCT ID: NCT01298466

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pregabalin

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

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081256&StudyName=Primary%20Care%20Identification%20Of%20Patients%20With%20Chronic%20Neuropathic%20Low%20Back%20Pain%20Study

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

Other Identifiers

A0081256

Identifier Type: -

Identifier Source: org_study_id