- Trials with a EudraCT protocol (14)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (28)

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: Ruddy, J., Proops, D. W., Pearman, K., and Ruddy, H. Department of ENT Surgery, Birmingham Children's Hospital, U.K Management of epistaxis in children Int.J.Pediatr.Otorhinolaryngol. 1991;21:139-142. |
Active substance: CHLORHEXIDINE_AND_NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 23935 |
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: A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. Roland PS, Younis R, Wall GM. Adv Ther. 2007 May-Jun;24(3):671-5. A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. Roland PS, Younis R, Wall GM. Adv Ther. 2007 May-Jun;24(3):671-5. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): |
View full study record |
Document reference: 24235 |
Study title: A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. Roland PS, Younis R, Wall GM. Adv Ther. 2007 May-Jun;24(3):671-5. Ear Drops and Otosporin Ear Drops in otitis externa. Bain DJ. J Int Med Res. 1976;4(1):79-81.A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. Roland PS, Younis R, Wall GM. Adv Ther. 2007 May-Jun;24(3):671-5. Ear Drops and Otosporin Ear Drops in otitis externa. Bain DJ. J Int Med Res. 1976;4(1):79-81. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24257 |
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: Ofloxacin otic drops vs neomycin-polymyxin B otic drops as prophylaxis against early postoperative tympanostomy tube otorrhea. Poetker DM, Lindstrom DR, Patel NJ, Conley SF, Flanary VA, Link TR, Kerschner JE. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1294-8. Ofloxacin otic drops vs neomycin-polymyxin B otic drops as prophylaxis against early postoperative tympanostomy tube otorrhea. Poetker DM, Lindstrom DR, Patel NJ, Conley SF, Flanary VA, Link TR, Kerschner JE. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1294-8. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24279 |
Study title: Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa. Schwartz RH. Curr Med Res Opin. 2006 Sep;22(9):1725-36. Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa. Schwartz RH. Curr Med Res Opin. 2006 Sep;22(9):1725-36. |
Active substance: CIPROFLOXACIN HYDROCORTIZONE |
Study summary document link (including results): |
View full study record |
Document reference: 24280 |
Study title: Post-marketing surveillance study of Seractil 200 mg and 300 mg film-coated tablets involving 1400 patients with rheumatic diseases. Phelps W. et al.. (Nov 1994): Final report Gebro; English translation, original report (in German language).Post-marketing surveillance study of Seractil 200 mg and 300 mg film-coated tablets involving 1400 patients with rheumatic diseases. Phelps W. et al.. (Nov 1994): Final report Gebro; English translation, original report (in German language). |
Active substance: DEXAMETHASONE AND NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 25750 |
Study title: Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. |
Active substance: DEXAMETHASONE AND NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 25744 |
Study title: Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections. Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8. Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections. Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8. |
Active substance: DEXAMETHASONE AND NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 25748 |
Study title: Vernal keratoconjunctivitis in the black child and its response to therapy.Dahan E, Appel R. Br J Ophthalmol. 1983 Oct;67(10):688-92. Vernal keratoconjunctivitis in the black child and its response to therapy.Dahan E, Appel R. Br J Ophthalmol. 1983 Oct;67(10):688-92. |
Active substance: DEXAMETHASONE AND NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 25747 |
Study title: |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): Neomycin sulfate-polymixin B-Dexmthasone - C-94-28.xls |
View full study record |
Document reference: 47627 |
Study title: A prospective randomized study of medications after silicone intubation. Liu D. Ophthalmic Surg Lasers. 1996 Jun;27(6):434-7. A prospective randomized study of medications after silicone intubation. Liu D. Ophthalmic Surg Lasers. 1996 Jun;27(6):434-7. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): A prospective randomized study of medications.pdf |
View full study record |
Document reference: 25763 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25757 |
Study title: [Epidemic keratoconjunctivitis: treatment results during an epidemic] Hutter H. Klin Monatsbl Augenheilkd. 1990 Sep;197(3):214-7. [Epidemic keratoconjunctivitis: treatment results during an epidemic] Hutter H. Klin Monatsbl Augenheilkd. 1990 Sep;197(3):214-7. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25761 |
Study title: Ocular hypertensive response to topical dexamethasone in children: a dose-dependent phenomenon.Ng JS, Fan DS, Young AL, Yip NK, Tam K, Kwok AK, Lam DS. Ophthalmology. 2000 Nov;107(11):2097-100 Comment in: Ophthalmology. 2001 Oct;108(10):1715-6. PMID: 11581031. Ocular hypertensive response to topical dexamethasone in children: a dose-dependent phenomenon.Ng JS, Fan DS, Young AL, Yip NK, Tam K, Kwok AK, Lam DS. Ophthalmology. 2000 Nov;107(11):2097-100 Comment in: Ophthalmology. 2001 Oct;108(10):1715-6. PMID: 11581031. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25756 |
Study title: Ocular-hypertensive response to topical steroids in children. Kwok AK, Lam DS, Ng JS, Fan DS, Chew SJ, Tso MO. Ophthalmology. 1997 Dec;104(12):2112-6. Ocular-hypertensive response to topical steroids in children. Kwok AK, Lam DS, Ng JS, Fan DS, Chew SJ, Tso MO. Ophthalmology. 1997 Dec;104(12):2112-6. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25759 |
Study title: Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25758 |
Study title: Vernal keratoconjunctivitis in the black child and its response to therapy.Dahan E, Appel R. Br J Ophthalmol. 1983 Oct;67(10):688-92.. Vernal keratoconjunctivitis in the black child and its response to therapy.Dahan E, Appel R. Br J Ophthalmol. 1983 Oct;67(10):688-92.. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
Study summary document link (including results): |
View full study record |
Document reference: 25760 |