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Ibuprofen

Generic Name
Ibuprofen
Brand Names
Addaprin, Advil, Advil Cold and Sinus, Advil Congestion Relief, Advil PM, Advil Sinus Congestion and Pain, Alivio, Caldolor, Cedaprin, Children's Ibuprofen, Diphen, Duexis, Ibu, Ibutab, Junior Strength Motrin, Motrin, Motrin PM, Neoprofen, Nuprin, Pedea, Proprinal, Reprexain, Sudafed PE Head Congestion Plus Pain, Vicoprofen, Wal-profen Congestion Relief and Pain, Ibuprofen Gen.Orph
Drug Type
Small Molecule
Chemical Formula
C13H18O2
CAS Number
15687-27-1
Unique Ingredient Identifier
WK2XYI10QM
Background

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin. Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID.

On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.

Indication

Ibuprofen is the most commonly used and prescribed NSAID. It is a very common over-the-counter medication widely used as an analgesic, anti-inflammatory and antipyretic.

The use of ibuprofen and its enantiomer Dexibuprofen in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder.

Due to its activity against prostaglandin and thromboxane synthesis, ibuprofen has been attributed to alteration of platelet function and prolongation of gestation and labour.

As ibuprofen is a widely used medication, the main therapeutic indications are:

Associated Conditions
Acute Pain, Ankylosing Spondylitis (AS), Common Cold, Cystic Fibrosis (CF), Fever, Gastric Ulcer, Gout, Headache, Insomnia, Juvenile Idiopathic Arthritis (JIA), Menstrual Distress (Dysmenorrhea), Migraine, Mild pain, Nasal Congestion, Osteoarthritis (OA), Pain, Pain, Inflammatory, Patent Ductus Arteriosus (PDA), Pericarditis, Primary Dysmenorrhoea, Rheumatoid Arthritis, Severe Pain, Sinus pressure, Mild to moderate pain, Minor aches and pains, Moderate Pain

Drotaverine in Dysmenorrhoea Treatment

First Posted Date
2006-02-16
Last Posted Date
2017-08-08
Lead Sponsor
Sanofi
Target Recruit Count
480
Registration Number
NCT00292747
Locations
🇭🇺

Sanofi-Aventis, Budapest, Hungary

A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

Phase 3
Completed
Conditions
Osteoarthritis
First Posted Date
2005-12-23
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
528
Registration Number
NCT00269191

Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Phase 4
Completed
Conditions
Fever
Interventions
First Posted Date
2005-12-20
Last Posted Date
2012-05-09
Lead Sponsor
Penn State University
Target Recruit Count
60
Registration Number
NCT00267293
Locations
🇺🇸

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

Not Applicable
Withdrawn
Conditions
Mental Disorders
First Posted Date
2005-11-28
Last Posted Date
2012-09-25
Lead Sponsor
Norwegian University of Science and Technology
Registration Number
NCT00258791

Use of Ibuprofen to Prevent IUD Site Effects

Phase 3
Completed
Conditions
IUD Removal
First Posted Date
2005-10-25
Last Posted Date
2006-10-17
Lead Sponsor
FHI 360
Target Recruit Count
2019
Registration Number
NCT00243815
Locations
🇨🇱

43 Ministry of Health facilities, Santiago, Chile

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

Phase 4
Completed
Conditions
Pain
Interventions
First Posted Date
2005-10-18
Last Posted Date
2015-06-19
Lead Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Target Recruit Count
224
Registration Number
NCT00240864

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.

Phase 4
Completed
Conditions
Pain
Interventions
First Posted Date
2005-10-18
Last Posted Date
2015-06-19
Lead Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
Target Recruit Count
222
Registration Number
NCT00240825

BONSAI: Biomarkers of Nonsteroidal Anti-Inflammatories

Phase 1
Conditions
Alzheimer's Disease
Interventions
Drug: Placebo
First Posted Date
2005-10-17
Last Posted Date
2009-04-29
Lead Sponsor
National Institute on Aging (NIA)
Target Recruit Count
40
Registration Number
NCT00239746
Locations
🇺🇸

Layton Aging & Alzheimer's Disease Center, Portland, Oregon, United States

A Study of Caldolor in Hospitalized Febrile Pediatric Patients

Phase 3
Completed
Conditions
Fever
First Posted Date
2005-09-26
Last Posted Date
2010-04-12
Lead Sponsor
Cumberland Pharmaceuticals
Registration Number
NCT00225706
Locations
🇿🇦

Unitas Hospital, Lyttleton, Pretoria, South Africa

🇺🇸

Vanderbilt University Children's Hospital, Nashville, Tennessee, United States

🇵🇦

Hospital Cecilio Castillero, Chitre, Herrera, Panama

Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients

Phase 3
Completed
Conditions
Pain
Interventions
Other: Normal saline as placebo comparator
First Posted Date
2005-09-26
Last Posted Date
2016-06-22
Lead Sponsor
Cumberland Pharmaceuticals
Target Recruit Count
319
Registration Number
NCT00225732
Locations
🇺🇸

Medical Center East / Alabama Clinical Therapeutics, Birmingham, Alabama, United States

🇺🇸

Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc., Mobile, Alabama, United States

🇺🇸

Jackson Hospital / Drug Research and Analysis Corporation, Montgomery, Alabama, United States

and more 10 locations
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