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Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

NCT01352741 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2019-10-28

Study results available
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Summary

The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring additional analgesia after titration to tapentadol PR 300 mg per day.

This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject reported outcomes. Since, severe low back pain with a neuropathic component, the targeted study population, is frequently treated with a combination therapy (monotherapy is often not effective enough) it is of interest to determine if tapentadol alone (combining 2 mechanisms of action in a single molecule) could be as effective as a combination of tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus combination are of interest.

Conditions

  • Low Back Pain
  • Neuropathic Pain

Interventions

DRUG

Tapentadol Prolonged Release

100 - 500 mg per day orally twice daily for a maximum of 12 weeks

DRUG

Tapentadol Prolonged Release with Pregabalin

Tapentadol Prolonged Release 100 - 300 mg per day with Pregabalin 150 - 300 mg per day orally twice daily for a maximum of 12 weeks

DRUG

Tapentadol Prolonged Release open label maintenance

100 - 400 mg per day Tapentadol Prolonged Release orally administered twice daily

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Ralf Baron, Prof. Dr. · Neurological pain research and therapy Clinic for Neurology Campus Kiel, University Clinic Schleswig-Holstein, Schittenhelmstr. 10, 24105 Kiel, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Germany
  • Netherlands
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352741 on ClinicalTrials.gov