- Trials with a EudraCT protocol (14,142)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (117)

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: A double-blind, 2 period, cross-over, placebo-controlled study evaluating three daily doses of 4mg BW825C. |
Active substance: ACRIVASTIN |
Study summary document link (including results): Study BW825C31UK-Acrivastine.xls |
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Document reference: 46909 |
Study title: The barium enema in constipation: comparison with rectal manometry and biopsy to exclude Hirschsprung's disease after the neonatal period. Reid JR. And al; Pediatric Radiology. 30(10):681-4, 2000 Oct.The barium enema in constipation: comparison with rectal manometry and biopsy to exclude Hirschsprung's disease after the neonatal period. Reid JR. And al; Pediatric Radiology. 30(10):681-4, 2000 Oct. |
Active substance: BARIUM SULPHATE |
Study summary document link (including results): |
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Document reference: 22205 |
Study title: Randomized, double-blind, 3-period crossover, exercise challenge study of 50 mcg and 100 mcg HFA-Beclometasone Dipropionate Autohaler and HFA-Placebo dosed once a day in children with asthma* |
Active substance: BECLAMETHASONE |
Study summary document link (including results): |
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Document reference: 22214 |
Study title: A single centre double-blind, double dummy, randomized 3 x 3 way cross over study to compare safety assessed by knemometry and urinary cortisol measurements of Beclomethasone Dipropionate HFA MDI 100 µg bid using Volumatic™ Spacer device and Beclomethasone Dipropionate CFC MDI 100 µg bid and 200 µg bid using Volumatic™ Spacer device in children with mild asthma during a 2–week treatment period. |
Active substance: BECLAMETHASONE |
Study summary document link (including results): Study DM-PR-3303-005-03 Beclometasone Dipropionate.xls |
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Document reference: 22224 |
Study title: A single centre double-blind, double dummy, randomized 3 x 3 way cross over study to compare safety assessed by knemometry and urinary cortisol measurements of Beclomethasone Dipropionate HFA (metered dose inhaler) 100 µg bid and Beclomethasone Dipropionate CFC MDI (metered dose inhaler) 100 µg bid and 200 µg bid in children with mild asthma during a 2 –week treatment period. |
Active substance: BECLAMETHASONE |
Study summary document link (including results): Study DM-PR-3303-004-03 Beclometasone Dipropionate.xls |
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Document reference: 22225 |
Study title: A single centre double-blind, double dummy, randomized 3x3 way cross over study to compare safety assessed by knemometry and urinary cortisol measurements of Beclomethasone Dipropionate HFA MDI 100 mcg bid using Volumatic Spacer device and Beclomethasone Dipropionate CFC MDI 100 mcg bid and 200 mcg bid using Volumatic Spacer device in children with mild asthma during a 2-week treatment period. |
Active substance: BECLAMETHASONE |
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Document reference: 22226 |
Study title: Double-blind, double-dummy, multinational, multicenter, parallel-group design clinical trial of the efficacy and tollerability of budesonide spray aereosol (200 mcg unit dose twice daily) administered via pMDI using the HFA-134a or the CFC propellant in a 12-week treatment period of mild to moderate persistent asthma in pediatric patients comparison with an open-label control group treated with budesonide HFA-134a (200 mcg unit dose twice daily) given with the `jet` spacer device |
Active substance: BUDESONIDE |
Study summary document link (including results): |
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Document reference: 45091 |
Study title: Symbicort® Turbuhaler® (formoterol/budesonide 4,5/160μg) in mild to moderate asthmatic patients - comparison of the efficacy of versatile dosing regimen with conventional constant dosing regimen during 12 weeks treatment period. |
Active substance: BUDESONIDE AND FORMOTEROL |
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Document reference: 23050 |
Study title: Efficacy and tolerability of amoxicillin/clavulanate versus cefaclor for a period of 10 days in the treatment of recurrent acute otitis media in children. |
Active substance: AMOXICILLIN AND CLAVUNALIC ACID |
Study summary document link (including results): Study 25000-559 Augmentin (as trihydrate).xls |
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Document reference: 46626 |
Study title: Open study to compare the caries reducing effect of a chlorhexidine varnish or a flouride varnish topically applied every 3rd month on the incidence of approximal caries in teenagers with a proven susceptibility to interdental enamel caries during a 3-year period.Petersson et al. (Caries Res 2000;34:140-143) |
Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication VOCO GmbH_Sodium flouride, Calcium flouride_2.xls |
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Document reference: 48185 |
Study title: 1 Month Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal Sprague Dawley Rat, Followed by a 3 Month Recovery Period. AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Montreal Inc, Sennevi |
Active substance: ESOMEPRAZOLE |
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Document reference: 26609 |
Study title: Dual effects of disopyramide on atrial and atrioventricular conduction and refractory periods - J.S BIRKHEAD - 1977 (British Heart Journal 1977, 39, 657-660)Dual effects of disopyramide on atrial and atrioventricular conduction and refractory periods - J.S BIRKHEAD - 1977 (British Heart Journal 1977, 39, 657-660) |
Active substance: DISOPYRAMIDE |
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Document reference: 26242 |
Study title: An Open, Two-Period, Crossover Study to Determine the Relative Bioavailability of the Enalapril Suspension 10 mg and Marketed VASOTEC™ 10-mg Tablets |
Active substance: ENALAPRIL |
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Document reference: 26370 |
Study title: RP54563: 13-week BID subcutaneous toxicity study in juvenile rats with a 6-week recovery period |
Active substance: ENOXAPARIN |
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Document reference: 26377 |
Study title: A single dose, randomised, double blind, double dummy, placebo controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of FormoterolHFA pMDI 12 mg per actuation administered by means of a "spacer"device (AeroChamber PlusTM) with that of Formoterol-HFA pMDI 12 mg per actuation in 5 to 12 yesar old children with persistent moderate to severe asthma. |
Active substance: FORMOTEROL |
Study summary document link (including results): CCD-0602-RS-0004 (Synopsis).doc |
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Document reference: 49213 |
Study title: Multicentre double-blind study of the efficacy and safety of 5mg cetirizine as a10mg/ml solution (drops) vs placebo, given orally with the evening meal over a two-weeks period to children aged 2 to years suffering from seasonal allergic rhinitis. |
Active substance: CETIRIZINE |
Study summary document link (including results): |
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Document reference: 23834 |
Study title: Selin BA, Ershov VL. Preventive analgesia and early postoperative period in ambulatory orthopaedic surgeries in children [Article in Russian] Anesteziol Reanimatol. 2004 Jan-Feb;(1):29-31.Selin BA, Ershov VL. Preventive analgesia and early postoperative period in ambulatory orthopaedic surgeries in children [Article in Russian] Anesteziol Reanimatol. 2004 Jan-Feb;(1):29-31. |
Active substance: DICLOFENAC |
Study summary document link (including results): |
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Document reference: 25982 |
Study title: MANAGEMENT OF FUNGAL INFECTIONS DURING THE REMISSION PERIOD OF LEUKEMIC PATIENTS; COMPARISON OF DIFLUCAN WITH AMPHOTERICIN B |
Active substance: FLUCONAZOLE |
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Document reference: 27488 |
Study title: MANAGEMENT OF FUNGAL INFECTIONS DURING THE REMISSION PERIOD OF LEUKEMIC PATIENTS; COMPARISON OF DIFLUCAN WITH AMPHOTERICIN B |
Active substance: FLUCONAZOLE |
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Document reference: 27852 |
Study title: ETAC (follow-up) early treatment of the atopic child (e.t.a.c.). evaluation of the efficacy and safety of cetirizine in preventing the onset of asthma in children who suffer from atopic dermatitis : a multi-country, double-blind, randomised, placebo-controlled trial. evaluation of the psychomotor and behavioural development during the last 3 months of treatment and during the 18-month post-treatment follow-up period. |
Active substance: CETIRIZINE |
Study summary document link (including results): 9322 - Cetirizine - MRCE99H1705.pdf |
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Document reference: 23802 |