Amoxicillin_clavulanate has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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amoxicillin_clavulanate studies

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Study IDPhaseTitle
611 IV A Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and Children.
25000/559 IV Efficacy and tolerability of amoxicillin/clavulanate versus cefaclor for a period of 10 days in the treatment of recurrent acute otitis media in children.
25000/563 IV A single-blind, randomized, multicentre, parallel group study to compare the efficacy and safety of Augmentin 500/125mg po bid versus Cefaclor 250mg po tid versus Cefuroxime 250mg po bid in the treatment of acute exacerbations of chronic bronchitis in Chinese adult patients.
25000/590 IV Ways of use in ENT practice of a new Augmentin formulation 1g/125mg (1 intake = 2 tablets 500mg/62.5mg) in treatment of acute sinusitis in adults.
Augmentin SSTIs 103997 IV An Open, Non-comparative study to evaluate the Efficacy & Safety of Augmentin 1 g (875 mg amoxicillin/125 mg clavulanic acid) po q 12 hours in the Treatment of Uncomplicated Skin and Soft tissue Infections in Pakistan.
233 III A Comparison of the Efficacy and Safety of Augmentin 875/125 mg po q 12 hrs and Augmentin 500/125 mg po q 8 hrs in the Treatment of Pyelonephritis and Complicated Urinary Tract Infections. A Double-Blind, Multi-Center, Comparative Study.
234 III A Comparison of the Efficacy and Safety of Augmentin 875/125 mg po q 12 hours versus Augmentin 500/125 mg po q 8 hours in the Treatment of Lower Respiratory Tract Infections.
311 III A comparison of the efficacy, safety and tolerability of Augmentin 60/15 mg/kg/day (4:1 ratio) given po in three divided doses versus Augmentin™ 70/10 mg/kg/day (7:1 ratio) given po in two divided doses in the treatment of children with acute otitis media. Augmentin is a registered trademark of the GlaxoSmithKline group of companies.
314 III A Comparison of the Efficacy and Safety of Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 10 days, Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 5 days, and Augmentin 40/10 mg/kg/day in Divided Doses q8h for 10 days in the Treatment of Acute Otitis Media in Children.
325 III A comparison of the efficacy, safety and tolerability of Augmentin tid 20/5 mg/kg/day po versus Augmentin bid 25/3.6 mg/kg/day po in the treatment of acute bacterial lower respiratory tract infections in children.
330 III A comparison of the efficacy, safety and tolerability of Augmentin 30/7.5 mg/kg/day po given in three divided doses (4:1 ratio) versus Augmentin 35/5 mg/kg/day po given in two divided doses (7:1 ratio) in the treatment of children with recurrent tonsillitis.
447 III A Comparison of the Safety and Efficacy of q 12 hrs Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomized Double-Blind, Multicenter, Comparative Study.
536 III An Open-Label Study to Demonstrate Bacteriological Efficacy of Augmentin ES in the Treatment of Acute Otitis Media Due to S. pneumoniae.
541 III The Effect of Antimicrobial Therapy for Otitis Media on Nasopharyngeal Pneumococcal Carriage and Antibiotic Resistance.
546 III A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral AugmentinÒ SR 2000/125mg Twice Daily Versus Oral AugmentinÒ 875/125mg Twice Daily for 7 Days in the Treatment of Adults with Bacterial Community Acquired Pneumonia
547 III An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125 mg Twice Daily for 7 days for the Treatment of Bacterial Community-Acquired Pneumonia in adults
548 III A Randomized, double-blind, double-dummy, multicenter, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 7 days versus oral clarithromycin 500mg twice daily for 7 days in the treatment of acute exacerbation of chronic bronchitis.
549 III A Randomised, Double-blind, Double-dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily for 7 days versus Oral Levofloxacin 500mg Once a Day for 7 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis.
550 III A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR, Two Tablets Equal to 2000/125mg, Twice Daily for 10 Days Versus Levofloxacin (Levaquin) 500mg Once Daily for 10 Days in the Treatment of Adults with Acute Bacterial Sinusitis Infections
551 III An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults
555 III Evaluating the Impact of Amoxicillin/Clavulanate Potassium Therapy on Carriage of Susceptible and Resistant Streptococcus pneumoniae.
556 III A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral amoxicillin/clavulanate (Augmentin SR) 2000/125mg twice daily for 10 days versus oral amoxicillin/clavulanate 1000/125mg three times daily for 10 days for the treatment of bacterial community acquired pneumonia in adults
557 III A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Three Times Daily for 7 or 10 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults.
591 III A double-blind, placebo-controlled, randomised, phase III clinical trial to compare the efficacy of oral Augmentin SR 2000/125 to placebo given as a single dose as prophylaxis or twice daily over 5 days as treatment to reduce the infective and inflammatory complications after undergoing maxillofacial surgery for third mandibular molar removal
592 III An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.
600 III A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 days in the Treatment of Adults with Bacterial Community Acquired Pneumonia.
620 III A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Three Times Daily for 7 or 10 Days in the Treatment of Adults with Community Acquired Pneumonia of Suspected Pneumococcal Origin.
627 III A Randomized, Double-Blind, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily for 5 Days Versus Oral Augmentin SR 2000/125mg Twice Daily for 7 Days in the Treatment of Adults with Acute Exacerbations of Chronic Bronchitis (AECB).
630 III A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis.
382 I A parallel group study to estimate the steady state pharmacokinetics of amoxicillin and clavulanate in paediatric patients in the age range 1 month to 12 years administered Augmentin® 45/6.4 mg/kg/day (twice daily) or 40/10 mg/kg/day (three times daily) orally
446 I Comparison of Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of Augmentin 45/3.2 mg/kg to Pediatric Patients with Acute Otitis Media
552 I A two-part crossover study to assess the pharmacokinetics of amoxicillin after administration with clavulanate of pharmacokinetically enhanced formulations of amoxicillin in healthy volunteers
553 I An open, randomised, balanced, three period, single dose crossover study to investigate the effect of food on the bioavailability of pharmacokinetically enhanced (PE) oral Augmentin® in healthy male and female volunteers
558 I An open, randomised, four-part crossover study to investigate the relative bioavailability of three new pharmacokinetically enhanced (PE) formulations of Augmentin in comparison to the standard immediate release (IR) formulation of Augmentin in healthy volunteers
574 I A study to determine the pharmacokinetic profiles of amoxicillin and clavulanate over a 12 hour dosing interval in paediatric patients in the weight range of 5 to 40 kg receiving Augmentin at 45/3.2 mg/kg orally every 12 hours for up to 10 days.
583 I An open, randomised, three way crossover study to investigate the effect of Maalox on the bioavailability of pharmacokinetically enhanced oral Augmentin (BRL 25000) in healthy male and female volunteers.
593 I A randomized open label, 4 period, crossover study to determine the bioequivalence of scored tablets of pharmacokinetically enhanced AUGMENTIN (administered as two tablets which have been broken in half) to unscored whole tablets of pharmacokinetically enhanced AUGMENTIN in healthy volunteers
601 I A Study to Determine the Bioequivalence of Reformulated Augmentin Suspension (improved stability) to Standard Marketed Suspension.
610 I A double blind study to compare the subject preference for Augmentin suspension formulations with alternative flavours in healthy paediatric subjects
643 I A Study to Determine the Bioequivalence of Reformulated AUGMENTIN ES-600 for Oral Suspension (improved flavor) to Standard Marketed Suspension
665 I An open-label, randomized, period balanced, replicate, four-period crossover bioequivalence study comparing AUGMENTIN ES-600 strawberry cream formulation to the marketed suspension.
25000/542 I Middle ear fluid penetration of augmentin paediatric formulation (100mg-12.5mg/ml) given as a 80mg-10mg/kg/day dosage regimen divided into three intakes.
25000/575 I A randomised, controlled and parallel phase I study to evaluate the selection of resistance to penicillin and erythromycin in the nasopharyngeal flora of adult healthy volunteers after a standard oral 7-day treatment of amoxicillin/clavulanic acid or clarithromycin or a 3-day treatment with azithromycin.
AUG102821 I An open-label study to determine the pharmacokinetic profiles of amoxicillin and clavulanate in adolescent patients weighing at least 40 kg and no more than 16 years of age receiving AUGMENTIN® XR (amoxicillin 2000 mg/clavulanate 125 mg), orally twice daily for 10 days