- Trials with a EudraCT protocol (2,084)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (79)
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: "Amiodarone therapy in children: efficacy and side effects. - Vignati G et al. - 1985 (G. Ital. Cardiol., 15: 786-794) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Amiodarone therapy in children: efficacy and side effects. - Vignati G et al. - 1985 (G. Ital. Cardiol., 15: 786-794) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
| Active substance: AMIODARONE |
| Study summary document link (including results): |
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| Document reference: 45225 |
| Study title: "Long term follow up of amiodarone therapy in the young: continued efficacy, unimpaired growth, moderate side effects. - Guccione P et al. - 1990 (J. Am. Coll. Cardiol., 15: 1118-1124) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CE" "Long term follow up of amiodarone therapy in the young: continued efficacy, unimpaired growth, moderate side effects. - Guccione P et al. - 1990 (J. Am. Coll. Cardiol., 15: 1118-1124) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CE" |
| Active substance: AMIODARONE |
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| Document reference: 45179 |
| Study title: "Optimal management o f amiodarone therapy: efficacy and side effects. - Hilleman D et al. - 1998 (Pharmacother., 18 (6 Pt 2): 138S-145S) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Optimal management o f amiodarone therapy: efficacy and side effects. - Hilleman D et al. - 1998 (Pharmacother., 18 (6 Pt 2): 138S-145S) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
| Active substance: AMIODARONE |
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| Document reference: 45184 |
| Study title: Higher frequency of early local side effects with aqueous versus depot immunotherapy for Hymenoptera venom allergy |
| Active substance: APIS MELIFERA-LYOPHILISED BEE VENOM |
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| Document reference: 21824 |
| Study title: Higher frequency of early local side effects with aqueous versus depot immunotherapy for Hymenoptera venom allergy |
| Active substance: Apis mellifera / Vespula spp. |
| Study summary document link (including results): |
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| Document reference: 39790 |
| Study title: Report/protocol/study N°: Controlled clinical study of ZY 15021 Investigator: C. Pulino Report date: 5 May 1986 Design: randomized, single-blind, comparative Objective: evaluation of efficacy and safety of ZY 15021 used with antibiotics Population: subjects with laryngo-pharyngo-tonsillar disorders Evaluations: pharyngeal pain, pain in swallowing, dysphonia, oropharyngeal inflammation; side effects Total (verum; comparator): 28 (14, 14) Age (mean, range): 13-57 years |
| Active substance: BENZOXONIUM CHLORIDE/BENZOXONIUM AND LIDOCAINE |
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| Document reference: 22304 |
| Study title: Report/protocol/study N°: Controlled clinical study of ZY 15021 Investigator: G. Sambuco Report date: 24 Jul 1986 Design: randomized, single-blind, comparative Objective: to compare the characteristics of ZY 15021 with those of cetylpyridinium chloride Population: patients with recurrent pharyngitis-laryngitis, post-surgical oropharynx inflammation Evaluations: pharyngeal pain, difficulty swallowing, dysphonia, inflammation; side effects Age (mean, range): 12-74 years (no details provided) |
| Active substance: BENZOXONIUM CHLORIDE/BENZOXONIUM AND LIDOCAINE |
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| Document reference: 22303 |
| Study title: Report/protocol/study N°: Clinical study on ZY 15021 Investigator: C. Galletti Report date: 30 Apr 1986 Design: open, non comparative Objective: evaluation of therapeutic efficacy and safety of ZY 15021 gelsolets, solution, oral spray Population: subjects with laryngo-pharyngo-tonsillar disorders with throat pain Evaluations: clinical symptoms, side effectsPeloso U.C. et al.: Penicillin concentrations in sera and tonsils after intramuscolar administration of benzathine penicillin G to children. Pediat.lnfect.Dis.J. 2003;22(12):1075-8 |
| Active substance: BENZENTHONIUM AND LIDOCAINE |
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| Document reference: 22284 |
| Study title: Report/protocol/study N°: Clinical trial of Orofar Investigator: A. Monteverde Report date: 18 Sep 1986 Design: open, non comparative Objective: Evaluation of efficacy and safety of Orofar gelsolets Population: subjects with acute pharyngitis or tonsillitis Evaluations: body temperature, pharyngeal pain, swallowing difficulties, dysphonia, inflammation, side effects |
| Active substance: BENZENTHONIUM AND LIDOCAINE |
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| Document reference: 22283 |
| Study title: Report/protocol/study N°: Controlled clinical study of ZY 15021 Investigator: C. Pulino Report date: 5 May 1986 Design: randomized, single-blind, comparative Objective: evaluation of efficacy and safety of ZY 15021 used with antibiotics Population: subjects with laryngo-pharyngo-tonsillar disorders Evaluations: pharyngeal pain, pain in swallowing, dysphonia, oropharyngeal inflammation; side effects |
| Active substance: BENZENTHONIUM AND LIDOCAINE |
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| Document reference: 22280 |
| Study title: Report/protocol/study N°: Controlled clinical study of ZY 15021 Investigator: G. Sambuco Report date: 24 Jul 1986 Design: randomized, single-blind, comparative Objective: to compare the characteristics of ZY 15021 with those of cetylpyridinium chloride Population: patients with recurrent pharyngitis-laryngitis, post-surgical oropharynx inflammation Evaluations: pharyngeal pain, difficulty swallowing, dysphonia, inflammation; side effects |
| Active substance: BENZENTHONIUM AND LIDOCAINE |
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| Document reference: 22279 |
| Study title: Report/protocol/study N°: Clinical study on ZY 15021 Investigator: C. Galletti Report date: 30 Apr 1986 Design: open, non comparative Objective: evaluation of therapeutic efficacy and safety of ZY 15021 gelsolets, solution, oral spray Population: subjects with laryngo-pharyngo-tonsillar disorders with throat pain Evaluations: clinical symptoms, side effects Total: 26 - gelsolets: 10 subjects - solution: 9 subjects - spray: 7 subjects Age (mean, range): 6-54 year |
| Active substance: BENZOYL PEROXIDE |
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| Document reference: 22308 |
| Study title: Report/protocol/study N°: Clinical trial of Orofar Investigator: A. Monteverde Report date: 18 Sep 1986 Design: open, non comparative Objective: Evaluation of efficacy and safety of Orofar gelsolets Population: subjects with acute pharyngitis or tonsillitis Evaluations: body temperature, pharyngeal pain, swallowing difficulties, dysphonia, inflammation, side effects Total: 20 Age (mean, range): 13-82 years |
| Active substance: BENZOYL PEROXIDE |
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| Document reference: 22307 |
| Study title: Effects of anesthetic technique on side effects associated with fentanyl Oralet premedication; Journal of Clinical Anesthesia 1997, 9(5): 374-8 |
| Active substance: FENTANYL |
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| Document reference: 27144 |
| Study title: Determination of an effective dose of fenoterol, as free as possible from side effects for regular therapeutic use in obstructive respiratory tract diseases. |
| Active substance: FENOTEROL |
| Study summary document link (including results): Fenoterol hydrobromide_U83-0224_synopsis.pdf |
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| Document reference: 27087 |
| Study title: Central nervous system side effects of first- and second-generation antihistamines in school children with perennial allergic rhinitis |
| Active substance: CETIRIZINE |
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| Document reference: 23711 |
| Study title: Central nervous system side effects of first- and second- generation antihistamines in school children with perennial allergic rhinitis: A randomized, double blind, placebo. Controlled comparative study |
| Active substance: CHLORPHENAMINE AND PARACETAMOL |
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| Document reference: 24044 |
| Study title: Side effects with use of oral transmucosal fentanyl; Pediatrics, 1995, 96(3 Pt 1): 544 |
| Active substance: FENTANYL |
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| Document reference: 27181 |
| Study title: Central nervous system side effects of first- and second- generation antihistamines in school children with perennial allergic rhinitis: A randomized, double blind, placebo. Controlled comparative study |
| Active substance: CHLORPHENAMINE AND TRAMAZOLINE |
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| Document reference: 24060 |
| Study title: Benesch M et al Outcome and long-term side effects after synchronous radiochemotherapy forchildhood brain stem gliomas Pediatr Neurosurg. 2001 Oct;35(4):173-80Benesch M et al Outcome and long-term side effects after synchronous radiochemotherapy forchildhood brain stem gliomas Pediatr Neurosurg. 2001 Oct;35(4):173-80 |
| Active substance: CYCLOPHOSPHAMIDE |
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| Document reference: 24766 |
