NCT00983385

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 Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

Completed Phase 3 Results posted Last updated 18 December 2018

What this trial tests

Phase 3 trial testing Tapentadol PR in Chronic Pain in 208 participants. Completed in 6 July 2010.

Timeline

30 September 2009

Primary endpoint
1 May 2010

6 July 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	208
Start date	30 September 2009
Primary completion	1 May 2010
Estimated completion	6 July 2010
Sites	46 locations across Austria, Croatia, France, Germany, Italy, Poland, Spain, Switzerland

Drugs / interventions tested

• Tapentadol PR — full drug profile →
• Observation period
• Tapentadol PR — full drug profile →

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

18 and older, any sex, with Chronic Pain or Low Back Pain. 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 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
  Time frame: Baseline; End of Week 6 (6 Weeks)
  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 participant assessment on the 0 to 10 scale. A negative value indicates a reduction in

Sponsor's own description

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) 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

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

1. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study.
   Steigerwald I, Müller M, Davies A, Samper D, et al · · 2012 · cited 62× · PMID 22443293 · DOI 10.1185/03007995.2012.679254
2. 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