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Serving leading biopharmaceutical companies globally:

Queensland Health
Cerilliant
McKinsey
Chinese Patent Office
Healthtrust
Fuji
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
Deloitte

Generated: November 19, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
NUCYNTA ER

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00472303 A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and MorphineCompletedJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 3 The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00472303 A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and MorphineCompletedGrünenthal GmbHPhase 3 The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR). *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
NCT00505414 A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and MorphineTerminatedJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 3 The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00505414 A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and MorphineTerminatedGrünenthal GmbHPhase 3 The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
NCT00982280 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.TerminatedGrünenthal GmbHPhase 3 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.
NCT00983073 Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular AnalgesicCompletedGrünenthal GmbHPhase 3 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.
NCT00986180 NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back PainCompletedGrünenthal GmbHPhase 3 Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
NCT00986180 NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back PainCompletedOrtho-McNeil Janssen Scientific Affairs, LLCPhase 3 Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
NCT01838616 Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.CompletedGrünenthal GmbHPhase 4 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.
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Conditions

Condition Name

Condition Name for NUCYNTA ER
Intervention Trials
Pain 3
Back Pain 2
Low Back Pain 2
Chronic Pain 2
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Condition MeSH

Condition MeSH for NUCYNTA ER
Intervention Trials
Chronic Pain 2
Low Back Pain 2
Back Pain 2
Osteoarthritis 2
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Trial Locations

Trials by Country

Trials by Country for NUCYNTA ER
Location Trials
United States 33
Germany 4
Spain 4
Argentina 4
Poland 3
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Trials by US State

Trials by US State for NUCYNTA ER
Location Trials
Indiana 2
Ohio 2
North Carolina 2
New York 2
Louisiana 2
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for NUCYNTA ER
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
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Clinical Trial Status

Clinical Trial Status for NUCYNTA ER
Clinical Trial Phase Trials
Completed 4
Terminated 2
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for NUCYNTA ER
Sponsor Trials
Grünenthal GmbH 6
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 2
Ortho-McNeil Janssen Scientific Affairs, LLC 1
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Sponsor Type

Sponsor Type for NUCYNTA ER
Sponsor Trials
Industry 9
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Serving leading biopharmaceutical companies globally:

Merck
US Department of Justice
Deloitte
Accenture
US Army
Boehringer Ingelheim
Johnson and Johnson
McKesson
Chinese Patent Office
Baxter

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