Tapentadol

Generic Name: Tapentadol

Brand Names: Nucynta

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₂₃NO

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

Clinical Trials

A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain

Phase 2

Completed

Conditions: Pain

Interventions: Drug: Morphine prolonged release
Drug: Tapentadol prolonged release

First Posted Date: 2014-05-30

Last Posted Date: 2019-09-12

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 73

Registration Number: NCT02151682

Locations: 🇭🇺
HU001, Budapest, Hungary
🇧🇬
BG006, Sofia, Bulgaria
🇨🇱
CL004, Santiago, Chile

and more 20 locations

A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

Phase 3

Completed

Conditions: Acute Pain

Interventions: Other: Placebo
Drug: Tapentadol oral solution 4 mg/mL
Drug: Tapentadol oral solution 20 mg/mL

First Posted Date: 2014-03-07

Last Posted Date: 2020-01-18

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 216

Registration Number: NCT02081391

Locations: 🇺🇸
US003, Dallas, Texas, United States
🇵🇱
PL005, Lodz, Poland
🇵🇱
PL002, Lublin, Poland

and more 40 locations

A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)
Drug: Tapentadol Prolonged-Release Formulation 2 (PR2)

First Posted Date: 2013-12-24

Last Posted Date: 2013-12-24

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Target Recruit Count: 64

Registration Number: NCT02019485

A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tapentadol ER 250-mg TRF tablet
Drug: Tapentadol ER 250-mg PR2 tablet

First Posted Date: 2013-11-11

Last Posted Date: 2013-11-14

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Target Recruit Count: 63

Registration Number: NCT01981278

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

Completed

Conditions: Neuropathic Pain
Tumor
Breakthrough Cancer Pain
Cancer Pain

Interventions: Drug: Morphine
Drug: Fentanyl
Drug: Methadone
Drug: Buprenorphine
Drug: Oxycodone
Drug: Hydromorphone
Drug: Tapentadol

First Posted Date: 2013-09-19

Last Posted Date: 2016-04-14

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 150

Registration Number: NCT01946555

Locations: 🇮🇹
A.O. Universitaria Parma, Parma, Italia, Italy
🇮🇹
Ospedale di Piacenza, Piacenza, Italy
🇮🇹
Ospedale Magati, Scandiano, Italia, Italy

and more 8 locations