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Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

NCT00982280 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-10-18

Study results available
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Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. 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 outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR treatment during defined periods of evaluation.

Conditions

Interventions

DRUG

Tapentadol PR

Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day. Maintenance Period: Participants continuing on the dose established in the previous period.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Barbara Hoggart, Dr. MD · FRCA, FRCAPM Heart of England NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2010-08-31

Countries

  • Australia
  • Denmark
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT00982280 on ClinicalTrials.gov