NCT00983073

An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

Completed Phase 3 Results posted Last updated 18 October 2019

What this trial tests

Phase 3 trial testing Tapentadol in Chronic Pain in 224 participants. Completed in 1 September 2010.

Timeline

1 September 2009

Primary endpoint
1 June 2010

1 September 2010

Quick facts

Lead sponsor	Grünenthal GmbH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	224
Start date	1 September 2009
Primary completion	1 June 2010
Estimated completion	1 September 2010
Sites	24 locations across France, Germany, Poland, Spain, United Kingdom

Drugs / interventions tested

• Tapentadol (TAPENTADOL) — full drug profile →

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

40 and older, any sex, with Chronic Pain or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.
  Time frame: Baseline to end of week 6
  For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity f

Sponsor's own description

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. 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 (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study.
   Steigerwald I, Müller M, Kujawa J, Balblanc JC, et al · · 2012 · cited 29× · PMID 22792000 · DOI 10.2147/jpr.s30540
2. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8
3. Driving Ability in Patients with Severe Chronic Low Back or Osteoarthritis Knee Pain on Stable Treatment with Tapentadol Prolonged Release: A Multicenter, Open-label, Phase 3b Trial.
   Sabatowski R, Scharnagel R, Gyllensvärd A, Steigerwald I. · · 2014 · cited 9× · PMID 25135385 · DOI 10.1007/s40122-014-0025-3