Lodotra® ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 5 |
46. 悪性関節リウマチ
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | NCT02072200 (ClinicalTrials.gov) | September 2013 | 14/2/2014 | Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) | A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness | Rheumatoid Arthritis | Drug: Lodotra® | Mundipharma Korea Ltd | NULL | Completed | 20 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 2 | EUCTR2007-003508-36-GB (EUCTR) | 02/07/2008 | 29/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Germany;United Kingdom | ||
| 3 | EUCTR2007-003508-36-HU (EUCTR) | 17/06/2008 | 18/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 4 | EUCTR2007-003508-36-DE (EUCTR) | 25/04/2008 | 28/03/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 5 | NCT00650078 (ClinicalTrials.gov) | March 2008 | 28/3/2008 | Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis | A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MR prednisone;Drug: Placebo | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | 80 Years | All | 350 | Phase 3 | United States;Canada;Germany;Hungary;Poland;United Kingdom |