Tapentadol
- Generic Name
- Tapentadol
- Brand Names
- Nucynta
- Drug Type
- Small Molecule
- Chemical Formula
- C14H23NO
- CAS Number
- 175591-23-8
- Unique Ingredient Identifier
- H8A007M585
- Background
Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake.
Tapentadol was first approved by the FDA on November 20, 2008. The extended-release formulation of tapentadol was also approved by the FDA on August 26, 2011. Used in the management of pain, tapentadol is typically reserved for patients who have limited alternative treatment options.
- Indication
用于治疗严重到需要阿片类镇痛剂且替代治疗不充分的急性疼痛。
- Associated Conditions
- Diabetic Peripheral Neuropathic Pain (DPN), Severe Acute Pain, Severe Pain
Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain
Phase 3
Completed
- Conditions
- Low Back Pain
- Interventions
- First Posted Date
- 2008-01-15
- Last Posted Date
- 2015-04-15
- Target Recruit Count
- 117
- Registration Number
- NCT00594516
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
Phase 3
Terminated
- Conditions
- PainNeoplasmCancer
- Interventions
- First Posted Date
- 2007-07-23
- Last Posted Date
- 2019-11-01
- Lead Sponsor
- Grünenthal GmbH
- Target Recruit Count
- 136
- Registration Number
- NCT00505414
- Locations
- 🇦🇷
054003, La Plata, Buenos Aires, Argentina
🇦🇷054012, Pergamino, Buenos Aires, Argentina
🇦🇷054015, Santa Fe, Argentina
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Phase 3
Completed
- Conditions
- PainOsteoarthritisLow Back Pain
- Interventions
- First Posted Date
- 2007-06-18
- Last Posted Date
- 2014-05-09
- Target Recruit Count
- 1166
- Registration Number
- NCT00487435
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Phase 3
Completed
- Conditions
- PainKnee Osteoarthritis
- Interventions
- Drug: Matching Placebo (twice daily)
- First Posted Date
- 2007-06-15
- Last Posted Date
- 2019-10-18
- Lead Sponsor
- Grünenthal GmbH
- Target Recruit Count
- 990
- Registration Number
- NCT00486811
- Locations
- 🇦🇹
Site 043002, Salzburg, Austria
🇭🇷Site 385002, Zagreb, Croatia
🇦🇹Site 043006, Mitterdorf, Austria
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Phase 3
Completed
- Conditions
- TumorPain
- Interventions
- Drug: Matching Placebo after Tapentadol in the Titration Phase.
- First Posted Date
- 2007-05-11
- Last Posted Date
- 2019-11-04
- Lead Sponsor
- Grünenthal GmbH
- Target Recruit Count
- 622
- Registration Number
- NCT00472303
- Locations
- 🇩🇪
Site 049014, Essen, Germany
🇭🇺Site 036003, Mátraháza, Hungary
🇷🇴Site 040003, Bucharest, Romania
A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
- First Posted Date
- 2007-04-03
- Last Posted Date
- 2013-07-19
- Target Recruit Count
- 395
- Registration Number
- NCT00455520
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
Phase 3
Completed
- Conditions
- Low Back Pain
- Interventions
- First Posted Date
- 2007-03-20
- Last Posted Date
- 2012-04-30
- Target Recruit Count
- 981
- Registration Number
- NCT00449176
Tapentadol (CG5503)
Phase 3
Completed
- Conditions
- Osteoarthritis, KneePain
- Interventions
- First Posted Date
- 2007-01-15
- Last Posted Date
- 2012-04-18
- Target Recruit Count
- 1030
- Registration Number
- NCT00421928
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Phase 3
Terminated
- Conditions
- Arthroplasty
- Interventions
- First Posted Date
- 2006-08-15
- Last Posted Date
- 2014-04-21
- Target Recruit Count
- 367
- Registration Number
- NCT00364533
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
Phase 3
Completed
- Conditions
- Osteoarthritis, HipLower Back PainOsteoarthritis, KneePain
- Interventions
- First Posted Date
- 2006-08-08
- Last Posted Date
- 2014-04-29
- Target Recruit Count
- 1123
- Registration Number
- NCT00361504
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