96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | JPRN-UMIN000015770 | 2014/09/01 | 01/12/2014 | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. | Crohn's disease (180 <= CDAI < 450)CDAI: Crohn's disease Activity Index | Standard therapy for Crohn's disease (Pentasa 3 g/day) Patients take curcumin or placebo | Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 30 | Not selected | Japan |
| 2 | NCT00862121 (ClinicalTrials.gov) | April 2009 | 13/3/2009 | A Study With Pentasa in Patients With Active Crohn's Disease | PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo. | Crohn´s Disease | Drug: Pentasa;Drug: Placebo | Ferring Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 20 | Phase 3 | United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain |
| 3 | NCT00245505 (ClinicalTrials.gov) | February 2009 | 26/10/2005 | The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's Disease | The Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot Study | Crohn's Disease | Drug: Mesalazine (Mesalamine) | Ferring Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | Both | 3 | Phase 3 | Sweden |
| 4 | EUCTR2008-002100-26-BE (EUCTR) | 28/01/2009 | 31/07/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 5 | EUCTR2008-002100-26-FR (EUCTR) | 16/01/2009 | 02/09/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 6 | EUCTR2008-002100-26-GB (EUCTR) | 07/01/2009 | 19/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Denmark;Belgium;France;Sweden | |||
| 7 | EUCTR2008-002100-26-SE (EUCTR) | 27/11/2008 | 08/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Denmark;Belgium;France;Sweden | |||
| 8 | EUCTR2008-002100-26-DE (EUCTR) | 19/11/2008 | 06/03/2009 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 9 | EUCTR2008-002100-26-DK (EUCTR) | 04/11/2008 | 18/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Belgium;Denmark;France;Sweden | |||
| 10 | JPRN-C000000300 | 2005/12/01 | 22/12/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - | Patients with Crohn's disease in active phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. | Zeria Pharmaceutical Co.,LTD | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 60 | Phase 3 | Japan | |
| 11 | JPRN-C000000301 | 2005/12/01 | 22/12/2005 | Z-206 Phase III Clinical Trial-Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase- | Patients with Crohn's disease in remission phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 40 | Phase 2,3 | Japan | |
| 12 | NCT00225810 (ClinicalTrials.gov) | October 2005 | 22/9/2005 | A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease | Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease | Crohn's Disease | Drug: Crohn's Disease | Ferring Pharmaceuticals | NULL | Completed | 8 Years | 18 Years | Both | 50 | Phase 4 | Czech Republic |
| 13 | EUCTR2005-002472-15-SE (EUCTR) | 22/09/2005 | 23/06/2005 | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | Mild to moderate active Crohn's disease MedDRA version: 7.1;Level: PT;Classification code 10011401 | Trade Name: Pentasa Sachet 1 g prolonged release granules Product Name: Pentasa Sachet 1 g INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicylic acid | Ferring Laegemidler A/S | NULL | Not Recruiting | Female: yes Male: yes | 10 | Sweden | |||
| 14 | NCT00167882 (ClinicalTrials.gov) | July 2005 | 9/9/2005 | The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: 5-aminosalicylate (Pentasa, Ferring) | VU University Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | |
| 15 | 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 |