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: C_₁₃H_₁₈O_₂

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: -

Clinical Trials

Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Completed

Conditions: Prematurity of Fetus
Patent Ductus Arteriosus

Interventions: Procedure: Surgical Ligation
Drug: Ibuprofen
Drug: Indomethacin

First Posted Date: 2011-09-02

Last Posted Date: 2016-04-06

Lead Sponsor: University of Ulm

Target Recruit Count: 35

Registration Number: NCT01428180

Locations: 🇩🇪
University Medical Center, Ulm, Baden-Württemberg, Germany

Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

Phase 3

Withdrawn

Conditions: Pain

Interventions: Drug: IBUPROFEN + CAFFEINE
Drug: IBUPROFEN

First Posted Date: 2011-09-01

Last Posted Date: 2012-11-27

Lead Sponsor: Sanofi

Registration Number: NCT01426971

Maxigesic 325 Acute Dental Pain Study

Phase 3

Completed

Conditions: Dental Pain

Interventions: Drug: Maxigesic 325
Drug: Acetaminophen
Drug: Ibuprofen
Drug: Placebo

First Posted Date: 2011-08-22

Last Posted Date: 2018-12-06

Lead Sponsor: AFT Pharmaceuticals, Ltd.

Target Recruit Count: 408

Registration Number: NCT01420653

Locations: 🇺🇸
Premier Research, Austin, Texas, United States
🇳🇿
Clinical Solutions Ltd., Auckland, New Zealand
🇳🇿
Clinical Trial New Zealand, Hamilton, Waikato, New Zealand

and more 1 locations

Maxi-Analgesic Osteoarthritis (OA) Study

Phase 3

Withdrawn

Conditions: Osteoarthritis

Interventions: Drug: Maxigesic 325
Drug: Placebo
Drug: Ibuprofen
Drug: Acetaminophen

First Posted Date: 2011-08-22

Last Posted Date: 2016-01-06

Lead Sponsor: AFT Pharmaceuticals, Ltd.

Registration Number: NCT01420666

Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants

Not Applicable

Conditions: Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants

Interventions: Drug: ibuprofen

First Posted Date: 2011-07-22

Last Posted Date: 2011-07-22

Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Target Recruit Count: 200

Registration Number: NCT01400737

Locations: 🇹🇷
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey

Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

Phase 4

Completed

Conditions: Pneumococcal Vaccines

Interventions: Biological: 13-valent pneumococcal conjugate vaccine
Biological: INFANRIX hexa
Drug: Paracetamol
Drug: Ibuprofen

First Posted Date: 2011-07-12

Last Posted Date: 2014-02-26

Lead Sponsor: Pfizer

Target Recruit Count: 908

Registration Number: NCT01392378

Locations: 🇵🇱
NZOZ Praktyka Lekarza Rodzinnego Eskulap, Lublin, Poland
🇵🇱
NZOZ Nasz Lekarz, Torun, Poland
🇵🇱
DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy, Warszawa, Poland

and more 11 locations