- Trials with a EudraCT protocol (847)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
Query did not match any clinical trials.
| 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: Antiemetic therapy for chemotherapy-induced vomiting: metoclopramide, benztropine, dexamethasone, and lorazepam regimen compared with chlorpromazine alone. |
| Active substance: BENZATROPINE |
| Study summary document link (including results): |
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| Document reference: 22243 |
| Study title: Antiemetic therapy for chemotherapy-induced vomiting: metoclopramide, benztropine, dexamethasone, and lorazepam regimen compared with chlorpromazine alone. |
| Active substance: BENZATROPINE |
| Study summary document link (including results): |
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| Document reference: 41947 |
| Study title: Randomised double blind comparative trial to evaluate the safety and efficacy of IV dolasetron mesilate (149) versus IV ondansetron (72) when both are used in combination with IV dexamethasone in the prevention of acute emesis due to moderately or highly emetogenic chemotherapy in paediatric patients - Dempsey- 09/1999 |
| Active substance: DOLASETRON |
| Study summary document link (including results): |
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| Document reference: 26304 |
| Study title: Ondansetron and dolasetron provide equivalent postoperative vomiting control after ambulatory tonsillectomy in dexamethasone pretreated children. Anaesth Anal. 2002; 95:1230-35 - Sukhani et al - 2002 - Publication in the GPE report reference Dolasetron mesilate safety review_Sept96-Jan06_02 (appendix 5) |
| Active substance: DOLASETRON |
| Study summary document link (including results): |
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| Document reference: 26296 |
| Study title: Ondansetron and dolasetron provide equivalent postoperative vomiting control after ambulatory tonsillectomy in dexamethasone pretreated children. Anaesth Anal. 2002; 95:1230-35 - Sukhani et al - 2002 - Publication in the GPE report reference Dolasetron mesilate safety review_Sept96-Jan06_02 (appendix 5)Ondansetron and dolasetron provide equivalent postoperative vomiting control after ambulatory tonsillectomy in dexamethasone pretreated children. Anaesth Anal. 2002; 95:1230-35 - Sukhani et al - 2002 - Publication in the GPE report reference Dolasetron mesilate safety review_Sept96-Jan06_02 (appendix 5) |
| Active substance: DOLASETRON |
| Study summary document link (including results): |
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| Document reference: 26307 |
| Study title: Quaranta CA. ZY15403 0.1% Diclofenac sodium ophthalmic solution (NACLOF DISPERSA DR 1200/1) in the anti-inflammatory treatment of chronic conjunctivitis. Double-blind controlled clinical study of efficacy and tolerance against 0.1% dexamethasone phosphate disodium ophthalmic solution. June 1, 1988. (3 paediatric patients, age 7, 11, 16 years)Quaranta CA. ZY15403 0.1% Diclofenac sodium ophthalmic solution (NACLOF DISPERSA DR 1200/1) in the anti-inflammatory treatment of chronic conjunctivitis. Double-blind controlled clinical study of efficacy and tolerance against 0.1% dexamethasone phosphate disodium ophthalmic solution. June 1, 1988. (3 paediatric patients, age 7, 11, 16 years) |
| Active substance: DICLOFENAC |
| Study summary document link (including results): |
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| Document reference: 26033 |
| Study title: Quaranta CA. ZY15403 0.1% Diclofenac sodium ophthalmic solution (NACLOF DISPERSA DR 1200/1) in the anti-inflammatory treatment of chronic conjunctivitis. Double-blind controlled clinical study of efficacy and tolerance against 0.1% dexamethasone phosphaQuaranta CA. ZY15403 0.1% Diclofenac sodium ophthalmic solution (NACLOF DISPERSA DR 1200/1) in the anti-inflammatory treatment of chronic conjunctivitis. Double-blind controlled clinical study of efficacy and tolerance against 0.1% dexamethasone phospha |
| Active substance: DICLOFENAC |
| Study summary document link (including results): |
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| Document reference: 26067 |
| Study title: Stodtmeister R and Marquardt A. Randomised double-blind comparative study of the effects of DR 1200/1 and dexamethasone 0.1% eye drops in patients with chronic irritative and chronic allergic conjunctivitis. 1986. (6 patients between 11 and 20 years)Stodtmeister R and Marquardt A. Randomised double-blind comparative study of the effects of DR 1200/1 and dexamethasone 0.1% eye drops in patients with chronic irritative and chronic allergic conjunctivitis. 1986. (6 patients between 11 and 20 years) |
| Active substance: DICLOFENAC |
| Study summary document link (including results): Voltaren Ophtha Paediatric Studies_Stodtmeister 1986_EMA spreadsheet.xls |
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| Document reference: 26070 |
| Study title: Van Husen H. Clinical double blind study to compare the action of DR 1200/1 diclofenac drops with that of dexamethasone phosphate eye drops in patients with episcleritis. September 16, 1985.(1 paediatric patient, age 1 year)Van Husen H. Clinical double blind study to compare the action of DR 1200/1 diclofenac drops with that of dexamethasone phosphate eye drops in patients with episcleritis. September 16, 1985.(1 paediatric patient, age 1 year) |
| Active substance: DICLOFENAC |
| Study summary document link (including results): Voltaren Ophtha Paediatric Studies_Van Husen 16-Sep-1985_EMA spreadsheet.xls |
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| Document reference: 26063 |
| Study title: A comparative fully randomized clinical study of FZ1000 (diclofenac eye drops 0,1%)vs dexamethasone in the managment of uveitis and episcleritis of the anterior eye segment in two paralell groups of paediatric patients followed by open continuation |
| Active substance: DICLOPHENAC |
| Study summary document link (including results): |
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| Document reference: 46919 |
| 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: CHLORAMPHENICOL_ CHLORAMPHENICOL +CORTISONE ACETATE +ETHACRIDINE LACTATE +ZINC OXIDE / CHLORAMPHENICOL AND MEDROXYPROGESTERONE AND TETRYZOLINE |
| Study summary document link (including results): Efficacy of diclofenac vs dexamethasone.pdf |
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| Document reference: 23872 |
| 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): |
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| 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): |
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| Document reference: 24235 |
| Study title: Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes.Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. |
| Active substance: CIPROFLOXACIN |
| Study summary document link (including results): |
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| Document reference: 24237 |
| Study title: Comment on Ocular hypertensive |
| Active substance: DEXAMETHASONE |
| Study summary document link (including results): Comment on Ocular hypertensive.pdf |
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| Document reference: 47190 |
| 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): |
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| Document reference: 24257 |
| Study title: Comment on ocular hypertensive response |
| Active substance: DEXAMETHASONE |
| Study summary document link (including results): Comment on ocular hypertensive response.pdf |
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| Document reference: 47191 |
| Study title: Efficacy of diclofenac vs dexamethasone |
| Active substance: DEXAMETHASONE |
| Study summary document link (including results): Efficacy of diclofenac vs dexamethasone.pdf |
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| Document reference: 47192 |
| Study title: Epidemic keratoconjunctivitis |
| Active substance: DEXAMETHASONE |
| Study summary document link (including results): Epidemic keratoconjunctivitis (in German).pdf |
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| Document reference: 47193 |
| Study title: Haney I, Lachance C, van Doesburg NH, Fouron J-C. Reversible steroid-induced hypertrophic cardiomyopathy with left ventricular outflow tract obstruction in two newborns. Am J Perinatology 1995;12,4:271-274. |
| Active substance: DEXAMETHASONE |
| Study summary document link (including results): |
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| Document reference: 25688 |
