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
-

Duloxetine Stress Urinary Incontinence Efficacy and Safety Study

Phase 3
Completed
Conditions
First Posted Date
2007-05-21
Last Posted Date
2007-05-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
120
Registration Number
NCT00475397
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., Seoul, Korea, Republic of

Duloxetine vs Placebo in the Treatment of General Anxiety

Phase 3
Completed
Conditions
First Posted Date
2007-05-21
Last Posted Date
2007-05-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
327
Registration Number
NCT00475969
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., Indianapolis, Indiana, United States

Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-05-09
Last Posted Date
2014-02-06
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
18
Registration Number
NCT00471315
Locations
🇺🇸

Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, United States

Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-04-24
Last Posted Date
2019-03-19
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
20
Registration Number
NCT00464698
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

A Study to Test the Use of Duloxetine for Pain in MS

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-04-06
Last Posted Date
2015-04-27
Lead Sponsor
Brown, Theodore R., M.D., MPH
Target Recruit Count
38
Registration Number
NCT00457730
Locations
🇺🇸

Evergreen Healthcare, Kirkland, Washington, United States

A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-03-06
Last Posted Date
2014-05-26
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
27
Registration Number
NCT00443352
Locations
🇺🇸

Jefferson Headache Center, Philadelphia, Pennsylvania, United States

The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-02-22
Last Posted Date
2016-04-27
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
15
Registration Number
NCT00438971
Locations
🇺🇸

The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital, Boston, Massachusetts, United States

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-02-09
Last Posted Date
2009-09-02
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
256
Registration Number
NCT00433290
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., Gothenburg, Sweden

Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

Not Applicable
Terminated
Conditions
First Posted Date
2007-01-22
Last Posted Date
2022-08-12
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
15
Registration Number
NCT00425230
Locations
🇺🇸

Micheal E. DeBakey Veterans Hospital, Houston, Texas, United States

Duloxetine Versus Placebo in Chronic Low Back Pain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-01-19
Last Posted Date
2009-11-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
236
Registration Number
NCT00424593
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 p, Rotterdam, Netherlands

© Copyright 2024. All Rights Reserved by MedPath