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
Associated Therapies
-

Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-07-28
Last Posted Date
2018-12-13
Lead Sponsor
Stanford University
Target Recruit Count
89
Registration Number
NCT01171794
Locations
🇺🇸

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

Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-07-27
Last Posted Date
2018-08-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
47
Registration Number
NCT01170637
Locations
🇩🇪

1024.7.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany

Bioequivalence Study of Ibuprofen 200 mg Soft Gel Capsules of Dr. Reddy's Laboratories Limited Under Fed Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-06-24
Last Posted Date
2010-06-29
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
30
Registration Number
NCT01149954
Locations
🇨🇦

Anaphann Inc., Quebec, Canada

Bioequivalence Study of Ibuprofen 200 mg Gel Capsules of Dr. Reddy's Laboratories Under Fasting Condition

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-06-24
Last Posted Date
2010-06-28
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
30
Registration Number
NCT01149941
Locations
🇨🇦

Anaphann Inc., Quebec, Canada

Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-05-26
Last Posted Date
2010-05-26
Lead Sponsor
Cumberland Pharmaceuticals
Target Recruit Count
123
Registration Number
NCT01131000
Locations
🇦🇺

Newcastle Mater Misericordiae Hospital, New Lambton, New South Wales, Australia

🇺🇸

Barnes Jewish Hospital, St. Louis, Missouri, United States

🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

and more 8 locations

Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Conditions
Interventions
First Posted Date
2010-04-07
Last Posted Date
2010-04-07
Lead Sponsor
Assaf-Harofeh Medical Center
Target Recruit Count
30
Registration Number
NCT01099462
Locations
🇮🇱

Assaf Harofeh, Zerifin, Israel

Study of Experimental Models of Pain and Inflammation.

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-04-02
Last Posted Date
2013-06-19
Lead Sponsor
Martin Angst
Target Recruit Count
15
Registration Number
NCT01097902
Locations
🇺🇸

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

Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2010-02-18
Last Posted Date
2012-06-07
Lead Sponsor
Shaare Zedek Medical Center
Registration Number
NCT01070745
Locations
🇮🇱

Shaare Zedek Medical Center, Jerusalem, Israel

Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee

First Posted Date
2010-02-10
Last Posted Date
2012-07-10
Lead Sponsor
Gebro Pharma GmbH
Target Recruit Count
482
Registration Number
NCT01066676
Locations
🇦🇹

Rheuma Zentrum Favoriten, Vienna, Austria

🇦🇹

Rehabzentrum für Erkrankungen des rheumat. Formenkreises, Bad Hofgastein, Salzburg, Austria

A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

First Posted Date
2010-02-08
Last Posted Date
2010-06-02
Lead Sponsor
Pfizer
Target Recruit Count
18
Registration Number
NCT01064726
Locations
🇺🇸

Pfizer Investigational Site, Omaha, Nebraska, United States

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