Neurologic Manifestations  >>  Palexia RP (tapentadol extended release)  >>  Phase 3
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7 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Palexia RP (tapentadol extended release) / Assertio, J&J, Grunenthal, Collegium Pharma
NCT00594516: Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

Completed
3
117
US
tapentadol (CG5503) Immediate Release IR, tapentadol (CG5503) Extended Release (ER), tapentadol (CG5503) Immediate Release (IR)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Grünenthal GmbH
Low Back Pain
04/08
05/08
NCT00449176: A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

Completed
3
981
US
tapentadol (CG5503) ER, oxycodone CR, placebo
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Grünenthal GmbH
Low Back Pain
05/08
05/08
NCT00361504: A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain

Completed
3
1123
US, Canada
Oxycodone CR, Tapentadol (CG5503) ER, CG5503
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Grünenthal GmbH
Osteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain, Pain
07/08
07/08
NCT00487435: An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

Completed
3
1166
US, Canada, RoW
Tapentadol (CG5503) Extended Release (ER)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Grünenthal GmbH
Pain, Osteoarthritis, Low Back Pain
06/09
06/09
NCT01063868: A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Terminated
3
47
US
Tapentadol extended release (ER), Oxycodone controlled release (CR)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Grünenthal GmbH
Diabetic Neuropathy, Painful, Diabetic Polyneuropathy
04/10
06/10
NCT00983385 / 2009-010427-12: Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics

Checkmark P3 data release chronic LBP (Pain)
Mar 2012 - Mar 2012: P3 data release chronic LBP (Pain)
Completed
3
208
Europe, RoW
Tapentadol PR, Palexia®, Nucynta®, Observation period
Grünenthal GmbH
Chronic Pain, Low Back Pain
05/10
07/10
NCT00986258 / 2009-010428-25: Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Checkmark
Mar 2013 - Mar 2013: 
Checkmark P3b low back pain data release (Pain)
May 2012 - May 2012: P3b low back pain data release (Pain)
Terminated
3
136
Europe, RoW
Tapentadol Prolonged Release, - Nucynta, - Palexia
Grünenthal GmbH
Pain, Chronic Pain, Low Back Pain, Neuropathic Pain, Nociceptive Pain
12/10
01/11

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