clavulanic acid
Trials 36 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04411914 | Sep 2020 → Nov 2021 | cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT03986762 | Mar → Dec 2019 | cocaine abuse, cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT02563769 | Oct 2016 → May 2018 | cocaine abuse, cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT02393586 | Feb → Oct 2015 | tuberculosis | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 1 | NCT00836901 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02571959 | Jul → Oct 2015 | obesity disorder | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05753735 | Jan → Mar 2024 | pancreas disorder | Case Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT05340257 | Oct 2023 → Jul 2024 | bacterial infectious disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 2 | NCT05562349 | May 2023 → Jul 2024 overdue | cocaine dependence | Temple University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02381470 | Feb → Sep 2019 | pulmonary tuberculosis | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 2 | NCT03435900 | Feb → Jul 2018 | appendicitis | Herlev Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01273376 | Dec 2010 → Sep 2011 | major depressive disorder | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00839176 | Jan → Sep 2009 | major depressive disorder | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00693056 | Jun 2008 → Mar 2009 | erectile dysfunction | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07556991 | Sep 2024 → Dec 2026 expected | — | University of Rostock | Recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07587450 | Sep 2026 → Sep 2029 expected | appendicitis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05224401 | May 2023 → Sep 2027 expected | bacterial urinary tract infection | Lund University | Recruiting | No outcome recorded |
| Phase 3 | NCT02764710 | May 2016 → May 2018 | — | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02007603 | Aug 2013 → Feb 2015 | infection-related hemolytic uremic syndrome | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT01524081 | Jul 2008 → Jul 2011 | appendicitis, intestinal obstruction, peptic ulcer perforation | The Faculty Hospital Na Bulovce | Completed | No outcome recorded |
| Phase 3 | NCT00161330 | Jun 2000 → Jul 2005 | urinary tract infection | University of Padova | Terminated | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT05830162 | Mar 2023 → Jan 2024 | infectious disease, obstetric disorder | Hanna Jangö | Completed | No outcome recorded |
| Phase 4 | NCT05394298 | Jul 2022 → Jul 2024 | Enterococcus infectious disease | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 4 | NCT04707092 | Jun 2021 → Jun 2022 | ear infection, poisoning | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 4 | NCT03574090 | Oct 2020 → May 2023 | — | Universitat Internacional de Catalunya | Completed | No outcome recorded |
| Phase 4 | NCT04400110 | Jun 2020 → Dec 2022 | urinary tract infection | IRCCS Burlo Garofolo | Completed | No outcome recorded |
| Phase 4 | NCT04082598 | Oct 2016 → Sep 2018 | — | Antonio Barone | Completed | No outcome recorded |
| Phase 4 | NCT01096927 | Jan 2010 → Jan 2011 | appendicitis | Maggiore Bellaria Hospital, Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00603317 | Mar 2008 → Mar 2010 | atrial fibrillation, pulmonary embolism, venous thromboembolism | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT00917592 | Dec 2005 → May 2008 | diverticulitis | Consorci Sanitari de Terrassa | Completed | No outcome recorded |
| Phase 4 | NCT00343135 | Dec 2004 → Mar 2005 | skin infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01559753 | Jan 1998 → Sep 2002 | — | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT03033147 | Oct 2019 → Mar 2020 | periapical periodontitis | Cairo University | Completed | No outcome recorded |
| — | NCT04350502 | Jul 2019 → Dec 2025 | empyema, pneumonia | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| — | NCT01356641 | Sep 2012 → Jan 2017 | appendicitis | Ramon R. Gorter | Completed | No outcome recorded |
| — | NCT00462020 | Mar 2007 → Nov 2008 | appendicitis | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
Also used as a comparator or background therapy in 27 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04376554 Comparator | Feb 2020 → Apr 2021 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07492134 Comparator | Jul 2026 → Apr 2028 expected | diverticulitis | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03713424 Comparator | Mar 2019 → Aug 2026 overdue | nicotine dependence | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06055257 Background | Jan 2025 → Dec 2027 expected | osteoradionecrosis of the mandible | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05392634 Comparator | Feb 2022 → Feb 2023 | urinary bladder cancer | N.N. Petrov National Medical Research Center of Oncology | Unknown | No outcome recorded |
| Phase 3 | NCT04549311 Comparator | Nov 2021 → Jan 2023 | anal fistula | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 3 | NCT02281929 Comparator | Jun 2015 → Nov 2019 | alcoholic hepatitis | University Hospital, Lille | Completed | No outcome recorded |
| Phase 3 | NCT02021006 Comparator | Dec 2013 → Jan 2020 | chronic kidney disease, renal hypodysplasia/aplasia 1, vesicoureteral reflux | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 3 | NCT00828971 Comparator | Nov 2008 → Sep 2009 | infectious disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00402727 Comparator | Sep 2006 → Jun 2008 | abscess, skin infection, ulcer disease | Bayer | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT04084106 Comparator | Sep 2019 → Nov 2022 | infectious disease | Uppsala University | Completed | No outcome recorded |
| Phase 4 | NCT03809312 Comparator | Aug 2019 → Dec 2020 | chronic rhinosinusitis | CHU de Quebec-Universite Laval | Unknown | No outcome recorded |
| Phase 4 | NCT03508921 Background | Jul 2018 → Jun 2022 | overactive bladder, urinary tract infection | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03247920 Comparator | Nov 2017 → Jun 2021 | neonatal sepsis | Franciscus Gasthuis | Completed | No outcome recorded |
| Phase 4 | NCT04110587 Comparator | Dec 2013 → Jul 2019 | temporomandibular joint dysfunction syndrome | Universidad Complutense de Madrid | Completed | No outcome recorded |
| Phase 4 | NCT02141217 Comparator | Mar → Dec 2013 | tooth disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00656747 Comparator | Mar 2008 → Dec 2010 | chronic bronchitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00495586 Comparator | Oct 2007 → Jul 2010 | chronic obstructive pulmonary disease | Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) | Completed | No outcome recorded |
| Phase 4 | NCT01583062 Comparator | Jan 2006 → Nov 2012 | — | Insel Gruppe AG, University Hospital Bern | Terminated | No outcome recorded |
| Phase 4 | NCT01166932 Comparator | Apr 2005 → Apr 2007 | pneumonia | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05840588 Background | Nov 2023 → Mar 2025 | bacterial infectious disease | Liaquat University of Medical & Health Sciences | Completed | No outcome recorded |
| — | NCT04856319 Comparator | Sep 2022 → Sep 2023 | tooth disorder | Biruni University | Unknown | No outcome recorded |
| — | NCT05248620 Comparator | Feb 2022 → Oct 2028 expected | — | Zealand University Hospital | Recruiting | No outcome recorded |
| — | NCT04803422 Comparator | Apr 2021 → May 2024 | appendicitis | Zealand University Hospital | Completed | No outcome recorded |
| — | NCT04438655 Background | May 2019 → Nov 2021 | — | University of Turin, Italy | Completed | No outcome recorded |
| — | NCT03362697 Comparator | Dec 2017 → Dec 2018 | bacterial urinary tract infection | Innovacion y Desarrollo de Estrategias en Salud | Completed | No outcome recorded |
| — | NCT00135603 Comparator | Feb 2004 → Feb 2008 | appendicitis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin And Clavulanate Potassium Chewable Tablets tevapharm.com ↗ |
| 2004-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin And Clavulanate Potassium For Oral Suspension, 200 mg and 400 mg tevapharm.com ↗ |
| 2004-03-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin/Clavulanate Potassium For Oral Suspension tevapharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | clavulanic acid | “The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella...” NCT02764710 ↗59“with initiation of antibiotic therapy at day 1 with Amoxicillin/clavulanic acid IntraVeinous (IV) in 2 doses daily for a minimum of 24 hours and a maximum of 48 hours with a...” NCT07587450 ↗ “Study participants were stratified by sex and block-randomised in a 1:1 ratio to treatment with either tebipenem pivoxil hydrobromide (600 mg orally every 8 h) or...” PMID 38432233 ↗ Feb 2024 “Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with...” NCT03362697 ↗ “A computer-generated randomisation sequence was used to allocate patients randomly in a 1:1 ratio to receive amoxicillin plus clavulanic acid (3 g per day) for 8-15 days or...” PMID 21550483 ↗ May 2011 “Study treatment includes amoxicillin + clavulanic acid (875mg/125mg) two times daily or clindamycin (150mg) four times daily for 5-7 days both administered orally with meal.” NCT02141217 ↗ “Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).” NCT04110587 ↗ “receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access” NCT05248620 ↗ “switch to an oral suspension of amoxicillin 75 mg/kg plus clavulanic acid 18·75 mg/kg (in a 4:1 dosing ratio, given daily in three doses)” PMID 36088952 ↗ Sep 2022 “Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week” NCT04707092 ↗ “IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days” NCT00828971 ↗ “active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%.” NCT03574090 ↗ “Amoxicillin+clavulanic acid at a daily dose of 3 gram / 375 mg in three daily doses of 1g/125mg, during 30 days” NCT02281929 ↗ “Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days.” NCT03508921 ↗ “Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.” NCT04438655 ↗ “* amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicillin)” NCT02021006 ↗ “2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment” NCT03033147 ↗ “amoxicillin-clavulanate:1 tablet [875 mg amoxicillin; 125 mg clavulanic acid] every 8 hours” NCT07492134 ↗ “Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery” NCT04856319 ↗ “Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days” NCT04082598 ↗ “Amoxicillin/clavulanic acid 875/125mg/8h if polymicrobial infection is suspected” NCT05394298 ↗ “Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily” NCT01356641 ↗ “Amoxicillin and clavulanic acid in fixed dose combination will be administered” NCT05340257 ↗ “First 6 month: Tablet Amoxicillin/Clavulanic Acid and Tablet Metronidazole.” NCT04803422 ↗ “2 g daily of Amoxicillin+Clavulanic acid 875/125 mg (1 g morning and night)” NCT06055257 ↗ “* Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS” NCT01559753 ↗ “500 mg amoxicillin combined with 125 mg clavulanic acid” NCT03435900 ↗ “Antibiotic Amoxicillin or Amoxicillin/Clavulanic acid” NCT05840588 ↗ “875mg Amoxicillin/125mg Clavulanic Acid” NCT00343135 ↗ |
| Known as | CLAV | “A Phase 1B Double Blind, Placebo (PBO) Controlled, Pharmaco- Magnetic Resonance Spectroscopy (MRS) Inpatient Study of Clavulanic Acid (CLAV) 500, 750, 1000 mg Daily Repeated...” NCT04411914 ↗1“A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)” NCT05562349 ↗ |
| Known as | clavulanate potassium | “Co-amoxiclav is an antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-lactamase inhibitor, clavulanate potassium.” NCT01583062 ↗ |
| Known as | RX-10100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00693056 ↗ |
| Action | Inhibit | “the ß-lactamase inhibitor, clavulanate potassium” NCT01583062 ↗ |
| Modality | Small molecule | “nonantibiotic small molecule beta-lactam compound” PMID 22203317 ↗ Dec 2011 |
| Route | Oral | “oral amoxicillin + clavulanic acid” NCT00161330 ↗ |