DeepMed Research

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

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Phase 2

Completed

Conditions: Low Back Pain

Interventions: Drug: High Dose GRT6005
Drug: Tapentadol
Drug: Low Dose GRT6005
Drug: Medium Dose GRT6005
Drug: Matching Placebo

First Posted Date: 2012-11-12

Last Posted Date: 2021-07-15

Lead Sponsor: Tris Pharma, Inc.

Target Recruit Count: 1089

Registration Number: NCT01725087

Locations: 🇫🇮
FI005, Kokkola, Finland
🇦🇹
AT001, Wien, Austria
🇦🇹
AT005, Wien, Austria

and more 76 locations

An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)

Phase 4

Withdrawn

Conditions: Chronic Back Pain
Pain
Chronic Low Back Pain
Osteoarthritis Pain In The Hip or Knee

Interventions: Drug: Nucynta ER

First Posted Date: 2012-06-29

Last Posted Date: 2018-01-25

Lead Sponsor: Janssen Scientific Affairs, LLC

Registration Number: NCT01631513

Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models

Phase 1

Terminated

Conditions: Allodynia
Hyperalgesia
Pain

Interventions: Drug: Tapentadol immediate release
Drug: placebo

First Posted Date: 2012-06-08

Last Posted Date: 2022-09-14

Lead Sponsor: University Hospital Schleswig-Holstein

Target Recruit Count: 24

Registration Number: NCT01615510

Locations: 🇩🇪
Department of Neurology, Kiel, Germany

Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)

Completed

Conditions: Substance Abuse Detection

Interventions: Drug: Oxycodone IR
Drug: Tapentadol IR

First Posted Date: 2012-03-07

Last Posted Date: 2012-10-29

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

Target Recruit Count: 646620

Registration Number: NCT01545778

A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

Phase 3

Completed

Conditions: Hallux Valgus

Interventions: Drug: Tapentadol IR 50 mg
Drug: Placebo
Drug: Tapentadol IR 75 mg

First Posted Date: 2012-01-24

Last Posted Date: 2014-04-28

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 353

Registration Number: NCT01516008

Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans

Phase 4

Completed

Conditions: Effects of 2 Mu-opiates on Gastrointestinal Transit

Interventions: Drug: Oxycodone
Drug: Placebo
Drug: Tapentadol

First Posted Date: 2011-12-28

Last Posted Date: 2012-12-17

Lead Sponsor: Mayo Clinic

Target Recruit Count: 38

Registration Number: NCT01500317

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Intravenous Tapentadol in Post-Bunionectomy Pain

Phase 2

Completed

Conditions: Bunion
Pain

Interventions: Drug: Matching Placebo
Drug: Tapentadol

First Posted Date: 2011-09-16

Last Posted Date: 2019-10-28

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 177

Registration Number: NCT01435577

Locations: 🇺🇸
Jean Brown Research, Salt Lake City, Utah, United States

Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

Phase 4

Completed

Conditions: Neuropathic Pain
Low Back Pain

Interventions: Drug: Tapentadol Prolonged Release
Drug: Tapentadol Prolonged Release with Pregabalin
Drug: Tapentadol Prolonged Release open label maintenance

First Posted Date: 2011-05-12

Last Posted Date: 2019-10-28

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 622

Registration Number: NCT01352741

Locations: 🇵🇱
Site 306, Ostrów Mazowiecka, Poland
🇦🇹
Site 504, Wien, Austria
🇦🇹
Site 505, Wien, Austria

and more 56 locations

A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: tapentadol (CG5503) ER two 100-mg TRF
Drug: tapentadol (CG5503) ER 25-mg TRF
Drug: tapentadol (CG5503) ER 50-mg TRF
Drug: tapentadol (CG5503) ER 100-mg TRF

First Posted Date: 2011-03-07

Last Posted Date: 2014-01-31

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

Target Recruit Count: 52

Registration Number: NCT01309425

A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

Phase 3

Completed

Conditions: Neoplasms

Interventions: Drug: Tapentadol ER
Drug: Morphine SR

First Posted Date: 2011-03-07

Last Posted Date: 2013-03-13

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 100

Registration Number: NCT01309386

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