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

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks
The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
Time Frame: 12 weeks
12 weeks
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
12 weeks
The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
Time Frame: 12 weeks
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2013

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (ESTIMATE)

February 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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