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

A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet

Phase 1

Completed

Conditions: Healthy Volunteer

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

First Posted Date: 2011-01-10

Last Posted Date: 2012-03-13

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

Target Recruit Count: 30

Registration Number: NCT01273532

A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet

Phase 1

Completed

Conditions: Healthy Volunteer

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

First Posted Date: 2011-01-10

Last Posted Date: 2012-03-13

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

Target Recruit Count: 30

Registration Number: NCT01273506

Tapentadol in Chronic Malignant Tumour Related Pain

Phase 3

Terminated

Conditions: Chronic Pain
Pain
Cancer

Interventions: Drug: Tapentadol Prolonged Release

First Posted Date: 2010-12-22

Last Posted Date: 2019-11-04

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 31

Registration Number: NCT01264887

Locations: 🇧🇬
Site 359004, Shumen, Bulgaria
🇲🇩
Site 373001, Chisinau, Moldova, Republic of
🇭🇺
Site 036010, Szekszard, Hungary

and more 9 locations

Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

Phase 2

Completed

Conditions: Postoperative Pain
Pain, Postoperative

Interventions: Drug: Tapentadol (OS) Oral Solution

First Posted Date: 2010-06-02

Last Posted Date: 2014-07-14

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 45

Registration Number: NCT01134536

A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia

Phase 2

Completed

Conditions: Pain
Diabetic Neuropathies
Neuralgia
Postherpetic Neuralgia

Interventions: Drug: Placebo
Drug: Tapentadol

First Posted Date: 2010-05-17

Last Posted Date: 2014-01-13

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 91

Registration Number: NCT01124617

An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

Phase 2

Completed

Conditions: Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee

Interventions: Drug: Tapentadol Hydrochloride
Drug: Placebo

First Posted Date: 2010-05-17

Last Posted Date: 2013-05-14

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 91

Registration Number: NCT01124604

A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Phase 3

Terminated

Conditions: Diabetic Neuropathy, Painful
Diabetic Polyneuropathy

Interventions: Drug: Tapentadol extended release (ER)
Drug: Oxycodone controlled release (CR)

First Posted Date: 2010-02-05

Last Posted Date: 2014-03-04

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

Target Recruit Count: 47

Registration Number: NCT01063868

A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

Phase 3

Completed

Conditions: Diabetic Peripheral Neuropathy

Interventions: Drug: Placebo
Drug: Tapentadol extended release (ER)

First Posted Date: 2010-01-01

Last Posted Date: 2013-09-11

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

Target Recruit Count: 460

Registration Number: NCT01041859

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

Phase 3

Completed

Conditions: Pain
Back Pain
Low Back Pain
Back Pain With Radiation

Interventions: Drug: Oxycodone IR
Drug: NUCYNTA

First Posted Date: 2009-09-29

Last Posted Date: 2012-12-19

Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Target Recruit Count: 667

Registration Number: NCT00986180

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Phase 3

Terminated

Conditions: Pain
Chronic Pain
Nociceptive Pain
Low Back Pain
Neuropathic Pain

Interventions: Drug: Tapentadol Prolonged Release

First Posted Date: 2009-09-29

Last Posted Date: 2019-01-09

Lead Sponsor: Grünenthal GmbH

Target Recruit Count: 136

Registration Number: NCT00986258

Locations: 🇧🇪
BE004, Brugge, Belgium
🇵🇱
PL002, Krakow, Poland
🇨🇭
CH002, St. Gallen, Switzerland

and more 24 locations

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