- Trials with a EudraCT protocol (1)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)

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, 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: 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: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142. |
Active substance: ACRIVASTIN |
Study summary document link (including results): |
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Document reference: 46222 |
Study title: Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142.Ones−Ü, Tamay−Z. New oral antihistamines in pediatrics and safety of antihistamines in children. Current Medicinal Chemistry: Anti−Inflammatory and Anti−Allergy Agents. 2005, Vol/Iss /Pg. 4/5 (495−506), ISSN: 1568−0142. |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 46231 |
Study title: Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold FormulaPhase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula |
Active substance: ACRIVASTIN AND PSEUDOEPHEDRINE |
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Document reference: 46248 |
Study title: A STUDY OF THE EFFICACY AND SAFETY OF ADAPALENE 0.1% AND 0.3% GEL IN THE TREATMENT OF ACTINIC KERATOSES IN ORGAN TRANSPLANT PATIENTS |
Active substance: ADAPALENE |
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Document reference: 46293 |
Study title: AN OPEN LABEL, CLINICAL SAFETY AND EFFICACY STUDY OF DIFFERIN (ADAPALENE) GEL IN THE TREATMENT OF FACIAL ACNE VULGARIS IN DARK PIGMENTED SKIN – SOUTH AFRICA |
Active substance: ADAPALENE |
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Document reference: 46261 |
Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1 % GEL VERSUS TRETINOIN 0.025 % GEL (WITH PARTICULAR REFERENCE TO ONSET OF ACTION) IN THE TREATMENT OF ACNE VULGARIS |
Active substance: ADAPALENE |
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Document reference: 46253 |
Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS ISOTRETINOIN 0.05% GEL IN THE TREATMENT OF ACNE VULGARIS |
Active substance: ADAPALENE |
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Document reference: 46292 |
Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS TRETINOIN 0.025% GEL IN THE TREATMENT OF ACNE VULGARIS – PHASE IV – CHINA |
Active substance: ADAPALENE |
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Document reference: 46262 |
Study title: CLINICAL SAFETY AND EFFICACY EVALUATION OF ADAPALENE 0.1% GEL VERSUS VEHICLE IN THE TREATMENT OF ACNE VULGARIS – Mexico |
Active substance: ADAPALENE |
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Document reference: 46259 |
Study title: CLINICAL STUDY PROTOCOL - EFFICACY AND SAFETY OF ADAPALENE GEL IN TWO CONCENTRATIONS (0.1% AND 0.03%) AND ITS VEHICLE IN THE TREATMENT OF JAPANESE SUBJECTS WITH ACNE VULGARIS |
Active substance: ADAPALENE |
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Document reference: 46289 |
Study title: COMPARISON OF EFFICACY AND SAFETY OF TETRALYSAL 300MG PLUS DIFFERIN GEL 0.1% VERSUS TETRALYSAL 300MG PLUS DIFFERIN GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS |
Active substance: ADAPALENE |
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Document reference: 46285 |
Study title: HALF-FACE COMPARISON OF THE SAFETY AND EFFICACY OF DIFFERIN (ADAPALENE GEL) GEL, 0.1% VERSUS TAZORAC (TAZAROTENE GEL) GEL, 0.1% AND RETIN-A MICRO (TRETINOIN GEL) GEL, 0.1% IN SUBJECTS WITH ACNE VULGARIS - PHASE IV |
Active substance: ADAPALENE |
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Document reference: 46272 |
Study title: SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE GEL) GEL, 0.1% AND RETIN-A GEL, 0.025% IN THE TREATMENT OF ACNE VULGARIS - PHASE IV |
Active substance: ADAPALENE |
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Document reference: 46267 |
Study title: SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE GEL) GEL, 0.1 % VERSUS RETIN-A CREAM, 0.05 % IN SUBJECTS WITH ACNE VULGARIS – PHASE IV |
Active substance: ADAPALENE |
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Document reference: 46258 |
Study title: US - A LONG TERM SAFETY AND EFFICACY STUDY OF ADAPALENE GEL, 0,3% IN SUBJECTS WITH ACNE VULGARIS |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46277 |
Study title: US - A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ADAPALENE/BENZOYL PEROXIDE TOPICAL GEL COMPARED WITH ADAPALENE TOPICAL GEL, 0.1%; BENZOYL PEROXIDE TOPICAL GEL, 2.5% AND TOPICAL GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS |
Active substance: ADAPALENE |
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Document reference: 46284 |
Study title: US - EFFICACY AND SAFETY OF ADAPALENE GEL, 0.3% COMPARED TO TAZAROTENE GEL, 0.1% IN THE TREATMENT OF ACNE VULGARIS - PHASE IIIB |
Active substance: ADAPALENE |
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Document reference: 46283 |
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 |