- Trials with a EudraCT protocol (12,689)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (1,156)

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: Clinical Study on the Efficacy and Tolerability of Acarbose (BAY g 5421) Compared with Placeboin Diabetic Children on Conventional Insulin Treatment, in Particular with Observation of the Glycemic Control Index ( PH-24820 ) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0665_study_synopsis.pdf |
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Document reference: 46158 |
Study title: Clinical Study to Investigate the Efficacy and Tolerability of Acarbose (BAY g 5421) Versus Placebo in Diabetic Children (PH 23433) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0634_study_synopsis.pdf |
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Document reference: 46155 |
Study title: Double-Blind, Cross-Over Clinical Study at a Single Centre to Compare Acarbose (BAY g 5421) with Placebo in Respect of Efficacy and Tolerability in Patients with Cystic Fibrosis and Pathological Glucose Tolerance (Pilot Study)(PH-26068) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0696_study_synopsis.pdf |
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Document reference: 46159 |
Study title: NON RANDOMISED FOLLW-UP STUDY WITH ACARBOSE-TREATMENT AND PRE- AND AFTER-TREATMENT WITH PLACEBO IN DIABETIC CHILDREN (TYPE I) STUDY 0428 (PH 14352) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0428_study_synopsis.pdf |
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Document reference: 46156 |
Study title: TREATMENT OF CHICKENPOX IN CHILDREN WITH ZOVIRAX SUSPENSION IN A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL |
Active substance: ACICLOVIR |
Study summary document link (including results): Study ZOVIRAX- 183 Aciclovir Oral.xls |
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Document reference: 46214 |
Study title: A double-blind, multicenter, multi-dose, parallel group, placebo-controlled study on the efficacy and safety of a homeopathic combination remedy vs.placebo over 14 days of treatment in children with acute otitis media. |
Active substance: Aconitum napellus Dil. D6 0,075 ml; Capsicum annuum Dil. D4 0,075 ml; Chamomilla recutita Ø 0,225 ml; Echinacea purpurea Ø 0,75 ml; Hydrargyrum bicyanatum Dil. D6 0,075 ml; Hydrastis canadensis Dil. D4 0,075 ml; Iodum Dil. D4 0,075 ml; Natrium tetraboracicum Dil. D4 0,075 ml; Sambucus nigra Ø 0,225 ml; Sanguinaria canadensis Ø 0,075 ml. |
Study summary document link (including results): |
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Document reference: 39772 |
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: Gibbs−T−G, McDonnell−K−A, Stokes−T, Graham−A−A. Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis. The British journal of clinical practice, {Br−J−Clin−Pract}, Jan 1989, vol. 43, no. 1, p. 11−4.Gibbs−T−G, McDonnell−K−A, Stokes−T, Graham−A−A. Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis. The British journal of clinical practice, {Br−J−Clin−Pract}, Jan 1989, vol. 43, no. 1, p. 11−4. |
Active substance: ACRIVASTIN |
Study summary document link (including results): |
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Document reference: 46224 |
Study title: Juhlin−L, Gibson−J−R, Harvey−S−G, Huson−L−W. Acrivastine versus clemastine in the treatment of chronic idiopathic urticaria. A double−blind, placebo−controlled study. International journal of dermatology, {Int−J−Dermatol}, Dec 1987, vol. 26, no. 10, p. 653−4.Juhlin−L, Gibson−J−R, Harvey−S−G, Huson−L−W. Acrivastine versus clemastine in the treatment of chronic idiopathic urticaria. A double−blind, placebo−controlled study. International journal of dermatology, {Int−J−Dermatol}, Dec 1987, vol. 26, no. 10, p. 653−4. |
Active substance: ACRIVASTIN |
Study summary document link (including results): |
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Document reference: 46225 |
Study title: Medical report of a double-blind, placebo-controlled, crossover study, to evaluate the efficacy and safety of 3 daily doses of 4 mg BW825C in children (6-13 yrs) exhibiting the symptoms of perennial allergic rhinitis, conducted by Dr. E.G. Weinberg, Cape Town, South Africa. Report No. BRAH/85/0011/00 |
Active substance: ACRIVASTIN |
Study summary document link (including results): Study H40-082-C86-Acrivastine.xls |
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Document reference: 46227 |
Study title: clinical study in the report N° FILIRF-FRZ0069-EN-E01: Comparison of oral lysine acetylsalicylate (Aspégic 500 ®) and a buffered aspirin (Bufferin ®) versus placebo for the relief of postoperative pain (3rd molar removal) - JF. Tecucianu, G. Bathelet, G. Narbonne - 1985 |
Active substance: ACETYL SALICYLIC ACID |
Study summary document link (including results): |
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Document reference: 46180 |
Study title: Gibbs−T−G, McDonnell−K−A, Stokes−T, Graham−A−A. Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis. The British journal of clinical practice, {Br−J−Clin−Pract}, Jan 1989, vol. 43, no. 1, p. 11−4.Gibbs−T−G, McDonnell−K−A, Stokes−T, Graham−A−A. Acrivastine in two doses compared with placebo in a multicentre, parallel group study for the treatment of seasonal allergic rhinitis. The British journal of clinical practice, {Br−J−Clin−Pract}, Jan 1989, vol. 43, no. 1, p. 11−4. |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 46233 |
Study title: Juhlin−L, Gibson−J−R, Harvey−S−G, Huson−L−W. Acrivastine versus clemastine in the treatment of chronic idiopathic urticaria. A double−blind, placebo−controlled study. International journal of dermatology, {Int−J−Dermatol}, Dec 1987, vol. 26, no. 10, p. 653−4.Juhlin−L, Gibson−J−R, Harvey−S−G, Huson−L−W. Acrivastine versus clemastine in the treatment of chronic idiopathic urticaria. A double−blind, placebo−controlled study. International journal of dermatology, {Int−J−Dermatol}, Dec 1987, vol. 26, no. 10, p. 653−4. |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 46234 |
Study title: Latte J et al. A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32Latte J et al. A randomized, double-blind, placebo-controlled trial of pseudoephedrine in coryza. Clin Exp Pharmacol Physiol 2004; 31(7): 429-32 |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 25809 |
Study title: A phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, and placebo in febrile children. Stat Rpt 32. Protocol 9-106, Unpublished Report 136. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL |
Study summary document link (including results): acetylsalicylic acid_paracetamol 9-106.pdf |
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Document reference: 47203 |
Study title: A phase IV double-blind single dose evaluation of the safety and efficacy of acetaminophen 1000 mg, aspirin 650 mg, and placebo in the treatment of pain following oral surgery. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL |
Study summary document link (including results): acetylsalicylic acid_paracetamol 2-231.pdf |
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Document reference: 47205 |
Study title: A phase IV double-blind single dose study of the efficacy and safety of acetaminophen 1000 mg, aspirin 1000 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 45. Protocol 3-251, Unpublished Report 157. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL |
Study summary document link (including results): acetylsalicylic acid_paracetamol 3-251.pdf |
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Document reference: 47204 |
Study title: A phase IV double-blind single dose study of the safety and efficacy of acetaminophen 1000 mg, Gemnisyn® 1300 mg, and placebo in the treatment of pain following oral surgery. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL |
Study summary document link (including results): acetylsalicylic acid_paracetamol 1-220.pdf |
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Document reference: 47207 |
Study title: Phase IV Double-Blind Single Dose Study of the Safety and Efficacy of Acetaminophen 1000 mg, Aspirin 650 mg, and Placebo in the Treatment of Pain Following Oral Surgery. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL |
Study summary document link (including results): acetylsalicylic acid_paracetamol 1-229.pdf |
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Document reference: 47206 |
Study title: phase IV double-blind multicenter study comparing the antipyretic effectiveness of aspirin, acetaminophen, choline salicylate and placebo in febrile children. |
Active substance: ACETYL SALICYLIC ACID AND PARACETAMOL AND CHOLINE SALICYLATE |
Study summary document link (including results): acetylsalicylic acid_choline salicylate_paracetamol 118.pdf |
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Document reference: 47208 |