At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 367 enrolled

Drug / intervention

Tapentadol Prolonged Release +1 moredrug

Likely dose

Tapentadol Prolonged Release 50 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01838616

NCT01838616Phase 4Completed

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Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus Oxycodone/Naloxone PR in Non-opioid Pre-treated Subjects With Uncontrolled Severe Chronic Low Back Pain With a Neuropathic Pain Component.

Grünenthal GmbH·interventional·Posted Apr 24, 2013·Updated Feb 24, 2016

In Brief

A Phase 4 clinical trial evaluating Tapentadol Prolonged Release and Oxycodone/Naloxone Prolonged Release for Back Pain and 2 related conditions. Completed, enrolled 367 participants across 50 sites in 4 countries.

Detailed Summary

This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a neuropathic pain component. Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBack Pain, Low Back Pain, Neuropathic Pain

CountriesAustria, Germany, Italy, Spain

Collaborators--

Timeline

Phase 4CompletedFinished

20132014201520162017201820192020202120222023202420252026

Enrollment StartApr 2013

First PostedApr 2013

Primary CompletionJan 2014

TodayJul 2026

First PostedApr 24, 2013

Enrollment StartApr 1, 2013

Primary CompletionJan 1, 2014

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 13.2 years ago

Interventions

Tapentadol Prolonged Releasedrug

All participants started with 50 mg tapentadol hydrochloride prolonged release (twice daily). The dose of tapentadol hydrochloride prolonged release will be adjusted in increments of 50 mg to a level that provided adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants are permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks.

Oxycodone/Naloxone Prolonged Releasedrug

All participants start with 10 mg/5 mg oxycodone/naloxone (twice daily). The dose of oxycodone/naloxone may be adjusted in increments of 10mg/ 5 mg oxycodone/naloxone to a level that provide adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants will be permitted a maximum dose of 50 mg/ 20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks.