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NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01524796
First received: December 12, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.


Condition Intervention
Peripheral Neuropathic Pain
 Other: No intervention. Non-interventional study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in average pain level during the past week. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Change from baseline in worst pain level during the past week. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Change from baseline in least pain level during the past week. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in pain-related sleep interference during the past week. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Patient's Global Impression of Change (PGIC). [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Health-related Quality of Life (EQ-5D). [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment (WPAI) questionnaire. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Pregabalin dose. [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]
  • Use of other pharmacological pain treatment for peripheral neuropathy (NeP). [ Time Frame: Baseline up to month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with peripheral neuropathic pain treated with Lyrica Other: No intervention. Non-interventional study
No intervention. Non-interventional study
Other Name: pregabalin (Lyrica)

Detailed Description:

General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.

Criteria

Inclusion Criteria:

  • Subjects aged 18 years or over.
  • Subjects diagnosed with peripheral neuropathic pain.

  • Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.

    1. for the first time ('first prescription patients') or
    2. that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients')
  • Subjects that haven't taken the first dose of the prescribed pregabalin yet.

Exclusion Criteria:

  • Subjects not consenting to participate.
  • Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524796

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01524796     History of Changes
Other Study ID Numbers: A0081292
Study First Received: December 12, 2011
Last Updated: April 29, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Pfizer:
Real-life
non-interventional
observational
 peripheral neuropathic pain
Lyrica
pregabalin

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013