- Trials with a EudraCT protocol (78)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (31)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Comparative evaluation of aztreonam and tobramycin plus azlocillin in pulmonary exacerbations of cystic fibrosis |
Active substance: AZTREONAM |
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Document reference: 46686 |
Study title: Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. |
Active substance: ERYTHROMYCIN |
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Document reference: 26566 |
Study title: [A nonsteroidal inflammation inhibitor in chronic conjunctivitis] Stodtmeister R, Marquardt R. Fortschr Ophthalmol. 1986;83(2):199-202. [A nonsteroidal inflammation inhibitor in chronic conjunctivitis] Stodtmeister R, Marquardt R. Fortschr Ophthalmol. 1986;83(2):199-202. |
Active substance: DICLOPHENAC AND TOBRAMYCIN |
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Document reference: 26092 |
Study title: Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. |
Active substance: DICLOPHENAC AND TOBRAMYCIN |
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Document reference: 26090 |
Study title: Preservative-free diclofenac sodium 0.1% for vernal keratoconjunctivitis. D'Angelo G, Lambiase A, Cortes M, Sgrulletta R, Pasqualetti R, Lamagna A, Bonini S. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):192-5;Epub 2003 Feb 15. Preservative-free diclofenac sodium 0.1% for vernal keratoconjunctivitis. D'Angelo G, Lambiase A, Cortes M, Sgrulletta R, Pasqualetti R, Lamagna A, Bonini S. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):192-5;Epub 2003 Feb 15. |
Active substance: DICLOPHENAC AND TOBRAMYCIN |
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Document reference: 26088 |
Study title: Treatment of severe lower respiratory tract infections with Ro 13-9904 |
Active substance: CEFTRIAXONE |
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Document reference: 23594 |
Study title: Prospective, Randomized, Third-Party Blind, Study to Compare the Safety and Efficacy of Ciprofloxacin (Sequential IV/PO) with intravenous Ceftazidime and Tobramycin in the Treatment of Pediatric Cystic Fibrosis Patients with Acute Pulmonary Exacerbation. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): 512.pdf |
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Document reference: 24224 |
Study title: A comparison of ciprofloxacin and tobramycin in bacterial conjunctivitis in children.Gross RD, Hoffman RO, Lindsay RN. Clin Pediatr (Phila). 1997 Aug;36(8):435-44 Comment in: Clin Pediatr (Phila). 1997 Aug;36(8):445-8. PMID: 9272317. A comparison of ciprofloxacin and tobramycin in bacterial conjunctivitis in children.Gross RD, Hoffman RO, Lindsay RN. Clin Pediatr (Phila). 1997 Aug;36(8):435-44 Comment in: Clin Pediatr (Phila). 1997 Aug;36(8):445-8. PMID: 9272317. |
Active substance: DEXAMETHASONE AND TOBRAMYCIN |
Study summary document link (including results): Comparison of ciprofloxacin and tobramycin in bacterial conj.pdf |
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Document reference: 25753 |
Study title: [Conjunctivitis of bacterial origin in children. Local antibiotic treatment with tobramycin collyrium] Fioretti GM, Campanari C. Pediatr Med Chir. 1989 Jul-Aug;11(4):421-3. [Conjunctivitis of bacterial origin in children. Local antibiotic treatment with tobramycin collyrium] Fioretti GM, Campanari C. Pediatr Med Chir. 1989 Jul-Aug;11(4):421-3. |
Active substance: DEXAMETHASONE AND TOBRAMYCIN |
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Document reference: 25754 |
Study title: Treatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops. Jackson WB, Low DE, Dattani D, Whitsitt PF, Leeder RG, MacDougall R. Can J Ophthalmol. 2002 Jun;37(4):228-37; discussion 237. Treatment of acute bacterial conjunctivitis: 1% fusidic acid viscous drops vs. 0.3% tobramycin drops. Jackson WB, Low DE, Dattani D, Whitsitt PF, Leeder RG, MacDougall R. Can J Ophthalmol. 2002 Jun;37(4):228-37; discussion 237. |
Active substance: DEXAMETHASONE AND TOBRAMYCIN |
Study summary document link (including results): Treatment of acute neonatal bacterial conjunctivitis.pdf |
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Document reference: 25752 |
Study title: COMPARATIVE EVALUATION OF CLINDAMYCIN VS CLINDAMYCIN PLUS TOBRAMYCIN IN THE TREATMENT OF PELVIC INFLAMMATORY DISEASE |
Active substance: CLINDAMYCIN |
Study summary document link (including results): M11000093 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 24368 |
Study title: Fusidic acid versus tobramycin in suspected bacterial conjunctivitis |
Active substance: FUSIDIC ACID |
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Document reference: 28680 |
Study title: A Formulation of Aerosolized Tobramycin (BramitobR) in the Treatment of Patients with Cystic Fibrosis and Pseudomonas aeruginosa Infection A Double-Blind, Placebo-Controlled, Multicenter StudyChuchalinet al, Pediatr Drugs 2007; 9 Suppl. 1: 21-31 |
Active substance: TOBRAMYCIN |
Study summary document link (including results): DM.RS.10000.002.04 publication.pdf |
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Document reference: 49196 |
Study title: Efficacy, Safety, and Local Pharmacokinetics of Highly Concentrated Nebulized Tobramycin in Patients with Cystic Fibrosis Colonized with Pseudomonas aeruginosaLenoir et al, Pediatr Drugs 2007; 9 Suppl. 1: 11-20, 1174-5878/07/0001-0011/ |
Active substance: TOBRAMYCIN |
Study summary document link (including results): DM.PR.10000.001.01 publication.pdf |
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Document reference: 49195 |
Study title: Tobramycin sulfate elimination in premature infants. Arbeter AM, Saccar CL, Eisner S, Sarni E, Yaffe SJ. J Pediatr. 1983 Jul;103(1):131-5. |
Active substance: TOBRAMYCIN |
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Document reference: 48896 |
Study title: A COMPARISON OF CEFOPERAZONE PLUS SULBACTAM VERSUS AMPICILLIN PLUS TOBRAMYCIN IN THE TREATMENT OF PATIENTS WITH BILIARY TRACT INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42655 |
Study title: Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. |
Active substance: TOBRAMYCIN |
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Document reference: 25751 |
Study title: Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9.Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. |
Active substance: TOBRAMYCIN |
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Document reference: 44821 |
Study title: A comparison of 0.3% Tobramycin Ophthalmic Solution (TOBREX New) vs TOBREX Ophthalmic Solution (TOBREX) for Treatment of Bacterial Conjunctivitis (C9998). |
Active substance: TOBRAMYCIN |
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Document reference: 44819 |
Study title: Clinical evaluation of TOBRADEX Ophthalmic Suspension versus Tobramycin Ophthalmic Solution (TOBREX) (C9192), |
Active substance: TOBRAMYCIN |
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Document reference: 44818 |