Duloxetine

Generic Name: Duloxetine

Brand Names: Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₉NOS

CAS Number: 116539-59-4

Unique Ingredient Identifier: O5TNM5N07U

Background: Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Indication: Indicated for:

1) Management of Major Depressive Disorder.

2) Management of Generalized Anxiety Disorder.

3) Management of diabetic peripheral neuropathy.

4) Management of fibromyalgia.

5) Management of chronic musculoskeletal pain.

6) Management of osteoarthritis of the knee in adults.

7) Management of chronic lower back pain in adults.

8) Management of stress urinary incontinence in adult women.

Off-label uses include:

1) Management of chemotherapy-induced peripheral neuropathy.

2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Associated Conditions: Chronic Lower Back Pain (CLBP), Chronic Musculoskeletal Pain, Diabetic Peripheral Neuropathic Pain (DPN), Fibromyalgia, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Osteoarthritis of the Knee, Stress Urinary Incontinence (SUI)

Associated Therapies: -

Clinical Trials

Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

Phase 3

Completed

Conditions: Parkinson's Disease

Interventions: Drug: placebo of duloxetine
Drug: duloxetine
Drug: injection of placebo of apomorphine
Drug: injection of apomorphine
Drug: injection of placebo of L-Dopa
Drug: L-Dopa

First Posted Date: 2012-01-05

Last Posted Date: 2017-02-23

Lead Sponsor: University Hospital, Toulouse

Target Recruit Count: 28

Registration Number: NCT01504178

Locations: 🇫🇷
CIC, Purpan Hospital, Toulouse, France

Improvement the Anti-migraine Treatment Efficacy by Tailoring the Drug to Individual's Pain Modulation Profile

Not Applicable

Completed

Conditions: Pain

Interventions: Drug: duloxetine

First Posted Date: 2011-11-11

Last Posted Date: 2015-09-17

Lead Sponsor: Rambam Health Care Campus

Target Recruit Count: 200

Registration Number: NCT01470339

Locations: 🇮🇱
MRI center, Haifa, Israel

Duloxetine for the Treatment of Chronic Pelvic Pain

Phase 4

Terminated

Conditions: Pelvis Pain Chronic

Interventions: Drug: Placebo
Drug: Duloxetine

First Posted Date: 2011-10-13

Last Posted Date: 2019-09-26

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 34

Registration Number: NCT01451606

Locations: 🇺🇸
University of Maryland, Baltimore, Baltimore, Maryland, United States

Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Duloxetine
Drug: Venlafaxine

First Posted Date: 2011-09-29

Last Posted Date: 2012-05-22

Lead Sponsor: Turku University Hospital

Target Recruit Count: 12

Registration Number: NCT01443520

Locations: 🇫🇮
Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital, Turku, Finland

Predicting Medication Response in Obsessive Compulsive Disorder

Not Applicable

Completed

Conditions: Obsessive Compulsive Disorder

Interventions: Drug: clomipramine
Drug: duloxetine
Drug: escitalopram

First Posted Date: 2011-07-28

Last Posted Date: 2013-01-31

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 26

Registration Number: NCT01404871

Locations: 🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇨🇦
The Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Inflammatory Markers and Cognitive Function in Major Depression

Phase 4

Conditions: Major Depression

Interventions: Drug: Duloxetine

First Posted Date: 2011-07-11

Last Posted Date: 2012-07-19

Lead Sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Target Recruit Count: 20

Registration Number: NCT01391221

Locations: 🇨🇦
Centre de Recherche Fernand Seguin, Montreal, Quebec, Canada
🇨🇦
Hôpital Maisonneuve Rosemont, Montreal, Quebec, Canada

Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

Phase 2

Completed

Conditions: Depression

Interventions: Drug: BMS-820836 Placebo
Drug: Duloxetine
Drug: Escitalopram
Drug: BMS-820836

First Posted Date: 2011-06-08

Last Posted Date: 2015-10-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 976

Registration Number: NCT01369095

Locations: 🇺🇸
Mclean Hospital, Belmont, Massachusetts, United States
🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States
🇺🇸
Pacific Clinical Research Medical Group, Orange, California, United States

and more 45 locations