Entocort (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 96 | Crohn disease | 6 |
| 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 | EUCTR2011-003743-22-IT (EUCTR) | 01/12/2011 | 08/03/2012 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entocort INN or Proposed INN: BUDESONIDE | ASTRAZENECA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | United States;Canada;Germany;Italy | |||
| 2 | NCT01453946 (ClinicalTrials.gov) | December 2011 | 14/10/2011 | Safety and Maintenance Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Perrigo Company | NULL | Completed | 5 Years | 17 Years | All | 55 | Phase 3 | United States;Canada;Germany;Italy;Poland |
| 3 | NCT01444092 (ClinicalTrials.gov) | November 2011 | 28/9/2011 | Safety Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Perrigo Company | NULL | Completed | 5 Years | 17 Years | All | 123 | Phase 3 | United States;Canada;Germany;Italy;Poland |
| 4 | EUCTR2011-003743-22-DE (EUCTR) | 20/10/2011 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide INN or Proposed INN: budesonide | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | United States;Canada;Poland;Germany;Italy | ||||
| 5 | EUCTR2011-003742-40-DE (EUCTR) | 20/10/2011 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide INN or Proposed INN: BUDESONIDE | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 50 | United States;Canada;Poland;Germany;Italy | ||||
| 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 |
| 6 | EUCTR2014-004132-20-Outside-EU/EEA (EUCTR) | 28/07/2016 | Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan | A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan | Active Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Entocort Product Code: D9421-C INN or Proposed INN: budesonide Trade Name: Pentasa INN or Proposed INN: mesalazine | AstraZeneca K.K. | NULL | NA | Female: yes Male: yes | 112 | Phase 3 | Japan |