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

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NCT01298466

Last updated on November 13, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain, Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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).

NCT01298466
Pfizer
Withdrawn
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study

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Descriptive Information
Brief Title  ICMJE Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
Official Title  ICMJE 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
Brief SummaryA0081256 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Low Back Pain
  • Neuralgia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Pregabalin
Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.
Intervention: Drug: Pregabalin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 17, 2012)		0
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2011)		600
Estimated Study Completion Date  ICMJE February 2013
Estimated Primary Completion DateFebruary 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298466
Other Study ID Numbers  ICMJE A0081256
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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