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Duloxetine

Generic Name
Duloxetine
Brand Names
Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly
Drug Type
Small Molecule
Chemical Formula
C18H19NOS
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
-

Evaluation of the Effects of Duloxetine on Norepinephrine

Phase 1
Completed
Conditions
Major Depressive Disorder
First Posted Date
2006-12-21
Last Posted Date
2007-06-12
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
35
Registration Number
NCT00414323
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas, United States

Duloxetine Versus Placebo for Osteoarthritis Knee Pain

Phase 3
Completed
Conditions
Osteoarthritis Knee Pain
Interventions
Drug: placebo
Drug: Duloxetine
First Posted Date
2006-12-07
Last Posted Date
2009-08-19
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
231
Registration Number
NCT00408421
Locations
🇷🇴

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Iasi, Romania

Duloxetine Versus Placebo in Chronic Low Back Pain

Phase 3
Completed
Conditions
Back Pain Without Radiation
Interventions
Drug: Duloxetine
Drug: Placebo
First Posted Date
2006-12-07
Last Posted Date
2009-12-29
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
404
Registration Number
NCT00408876
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph, Tampa, Florida, United States

An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome

Phase 4
Completed
Conditions
Irritable Bowel Syndrome
Interventions
First Posted Date
2006-11-20
Last Posted Date
2018-03-09
Lead Sponsor
Mclean Hospital
Target Recruit Count
15
Registration Number
NCT00401258
Locations
🇺🇸

McLean Hospital, Belmont, Massachusetts, United States

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Phase 4
Terminated
Conditions
Depression
Interventions
First Posted Date
2006-11-14
Last Posted Date
2017-11-17
Lead Sponsor
Stanford University
Target Recruit Count
6
Registration Number
NCT00398632
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Treatment With Duloxetine for OCD Patients

Not Applicable
Withdrawn
Conditions
OCD
First Posted Date
2006-11-14
Last Posted Date
2008-01-31
Lead Sponsor
Sheba Medical Center
Target Recruit Count
40
Registration Number
NCT00399022
Locations
🇮🇱

Chaim Sheba Medical Center, Ramat-Gan, Israel

Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

Not Applicable
Completed
Conditions
Low Back Pain
Interventions
Drug: duloxetine
Drug: Placebo
First Posted Date
2006-10-16
Last Posted Date
2017-12-11
Lead Sponsor
Stanford University
Target Recruit Count
14
Registration Number
NCT00388414
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers

Phase 1
Completed
Conditions
Hyperalgesia
Interventions
Drug: GSK189254
Drug: Duloxetine
Drug: GSK189254 Placebo
Drug: Duloxetine Placebo
First Posted Date
2006-10-13
Last Posted Date
2017-08-07
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
40
Registration Number
NCT00387413
Locations
🇬🇧

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

Phase 2
Completed
Conditions
Fatigue Syndrome, Chronic
Interventions
Drug: Placebo
Drug: Duloxetine
First Posted Date
2006-09-13
Last Posted Date
2015-08-21
Lead Sponsor
University of Cincinnati
Target Recruit Count
60
Registration Number
NCT00375973
Locations
🇺🇸

Women's Health Research Program, Cincinnati, Ohio, United States

Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

Phase 2
Completed
Conditions
Diabetes Mellitus
Peripheral Neuropathies
First Posted Date
2006-09-01
Last Posted Date
2009-11-17
Lead Sponsor
University of Surrey
Target Recruit Count
90
Registration Number
NCT00370656
Locations
🇬🇧

Poole General Hospital, Poole, Dorset, United Kingdom

🇬🇧

Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom

🇬🇧

University of Surrey Clinical Research Centre, Guildford, Surrey, United Kingdom

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