- Trials with a EudraCT protocol (115)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (8)

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: Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83.Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 24248 |
Study title: Dohar J, Giles W, Roland P, Bikhazi N, Carroll S, Moe R, Reese B, Dupre S, Wall M, Stroman D, McLean C, Crenshaw K. Pediatrics. 2006 Sep;118(3):e561-9;Epub 2006 Jul 31. Dohar J, Giles W, Roland P, Bikhazi N, Carroll S, Moe R, Reese B, Dupre S, Wall M, Stroman D, McLean C, Crenshaw K. Pediatrics. 2006 Sep;118(3):e561-9;Epub 2006 Jul 31. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 24238 |
Study title: Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83. Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24263 |
Study title: Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83. Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Roland PS, Pien FD, Schultz CC, Henry DC, Conroy PJ, Wall GM, Garadi R, Dupre SJ, Potts SL, Hogg LG, Stroman DW; Ciprodex Otic AOE Study Group. Curr Med Res Opin. 2004 Aug;20(8):1175-83. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24282 |
Study title: Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. Roland PS, Anon JB, Moe RD, Conroy PJ, Wall GM, Dupre SJ, Krueger KA, Potts S, Hogg G, Stroman DW. Laryngoscope. 2003 Dec;113(12):2116-22. Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes. Roland PS, Anon JB, Moe RD, Conroy PJ, Wall GM, Dupre SJ, Krueger KA, Potts S, Hogg G, Stroman DW. Laryngoscope. 2003 Dec;113(12):2116-22. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 24246 |
Study title: Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. Roland PS, Kreisler LS, Reese B, Anon JB, Lanier B, Conroy PJ, Wall GM, Dupre SJ, Potts S, Hogg G, Stroman DW, McLean C. Pediatrics. 2004 Jan;113(1 Pt 1):e40-6. ... |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 24226 |
Study title: Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. Roland PS, Kreisler LS, Reese B, Anon JB, Lanier B, Conroy PJ, Wall GM, Dupre SJ, Potts S, Hogg G, Stroman DW, McLean C. Pediatrics. 2004 Jan;113(1 Pt 1):e40-6. Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. Roland PS, Kreisler LS, Reese B, Anon JB, Lanier B, Conroy PJ, Wall GM, Dupre SJ, Potts S, Hogg G, Stroman DW, McLean C. Pediatrics. 2004 Jan;113(1 Pt 1):e40-6. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24266 |
Study title: Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. Dohar J, Giles W, Roland P, Bikhazi N, Carroll S, Moe R, Reese B, Dupre S, Wall M, Stroman D, McLean C, Crenshaw K. Pediatrics. 2006 Sep;118(3):e561-9;Epub 2006 Jul 31. Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. Dohar J, Giles W, Roland P, Bikhazi N, Carroll S, Moe R, Reese B, Dupre S, Wall M, Stroman D, McLean C, Crenshaw K. Pediatrics. 2006 Sep;118(3):e561-9;Epub 2006 Jul 31. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24259 |