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

Tapentadol vs Tramadol in Total Knee Arthroplasty

Phase 4

Recruiting

Conditions: Total Knee Replacement
Post-operative Pain
Chronic Pain

Interventions: Drug: Tramadol
Drug: Tapentadol

First Posted Date: 2024-02-21

Last Posted Date: 2024-05-14

Lead Sponsor: University of Thessaly

Target Recruit Count: 96

Registration Number: NCT06269770

Locations: 🇬🇷
University Hospital Of Larissa, Larissa, Thessaly, Greece

Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

Phase 4

Completed

Conditions: Lower Limb Fracture

Interventions: Drug: Tapentadol Hydrochloride

First Posted Date: 2023-08-21

Last Posted Date: 2023-08-21

Lead Sponsor: Kempegowda Institute of Medical Sciences, Bangalore

Target Recruit Count: 74

Registration Number: NCT05999890

Locations: 🇮🇳
Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India

Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)

Phase 1

Completed

Conditions: Pharmacokinetic

Interventions: Drug: Tapentadol IR capsule
Drug: Omeprazole capsule

First Posted Date: 2019-06-10

Last Posted Date: 2019-06-10

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 32

Registration Number: NCT03979989

Locations: 🇧🇪
J&JPRD Clinical Pharmacology Unit, Merksem, Belgium

Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Tapentadol Test Product 1
Drug: Tapentadol Test Product 2
Drug: Tapentadol Prolonged-release Reference Product

First Posted Date: 2019-05-20

Last Posted Date: 2019-05-20

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 10

Registration Number: NCT03956134

Locations: 🇩🇪
Department of Clinical Pharmacology, Grünenthal GmbH, Aachen, Germany

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery

Phase 4

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: Pregabalin 150mg
Drug: Tapentadol 100 MG Oral Tablet

First Posted Date: 2018-07-27

Last Posted Date: 2020-06-25

Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Target Recruit Count: 95

Registration Number: NCT03604354

Locations: 🇮🇳
All India Institute of Medical Sciences, Bhubaneswar, Odisha, India

Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty

Not Applicable

Completed

Conditions: Analgesia

Interventions: Drug: Placebo Oral Tablet
Drug: Tapentadol 100 MG

First Posted Date: 2017-11-24

Last Posted Date: 2018-09-10

Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Target Recruit Count: 90

Registration Number: NCT03351517

Locations: 🇮🇳
All India Institute of Medical Sciences, Bhubaneswar, Odisha, India

Effects of Tapentadol Versus Oxycodone After Hysterectomy.

Phase 4

Completed

Conditions: Pain, Postoperative
Pain Uterus
Pain, Acute
Opioid Use
Analgesics, Antipyretics, and Antirheumatics Causing Adverse Effects in Therapeutic Use
Visceral Pain