274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 91 / 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2004-000485-13-DK (EUCTR) | 29/01/2007 | 29/11/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta MedDRA version: 8.1;Level: LLT;Classification code 10031243;Term: Osteogenesis imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Trade Name: Optinate 5 mg filmcoated tablets Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 2 | EUCTR2004-000485-13-CZ (EUCTR) | 04/10/2006 | 25/08/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | Hungary;Czech Republic;Finland;Spain;Belgium;Denmark | ||
| 3 | EUCTR2004-000485-13-HU (EUCTR) | 25/08/2006 | 14/07/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Finland;Hungary;Czech Republic;Denmark;Spain | |||
| 4 | EUCTR2004-000485-13-BE (EUCTR) | 22/08/2006 | 30/05/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Czech Republic;Hungary;Finland;Spain;Belgium;Denmark | |||
| 5 | EUCTR2004-000485-13-FI (EUCTR) | 28/03/2006 | 10/02/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Trade Name: Actonel/Optinate 5mg film-coated tablets Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain |