Clipper ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎5

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000330-61-ES
(EUCTR)
16/05/201707/04/2017Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU studyEffect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCU Clinically inactive Ulcerative Colitis at risk of relapse
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Clipper
Product Name: Beclometasone dipropionate
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CHIESI ESPAÑA S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Spain
2EUCTR2006-004230-32-BE
(EUCTR)
21/12/200704/12/2007Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta studyEfficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study Ulcerative colitis extending proximally beyond the rectum.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Clipper 30 cpr 5mg R.M.
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
Trade Name: Deltacortene 20 cpr 5mg
INN or Proposed INN: PREDNISONE
Trade Name: Deltacortene 10 cpr 25mg
INN or Proposed INN: PREDNISONE
CHIESI Farmaceutici S.p.A.NULLNot RecruitingFemale: yes
Male: yes
300Belgium;Spain;Italy;Poland
3EUCTR2006-004230-32-PL
(EUCTR)
07/12/200705/09/2007EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Clipper
INN or Proposed INN: Beclomethasone diproprionate
Trade Name: Deltacortene
INN or Proposed INN: Prednisone
Trade Name: Deltacortene
INN or Proposed INN: Prednisone
Chiesi Farmaceutici SpANULLNot RecruitingFemale: yes
Male: yes
300Phase 3Belgium;Spain;Poland;Italy
4EUCTR2006-004230-32-ES
(EUCTR)
22/08/200726/09/2007EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETAEFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Clipper
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
Trade Name: Deltacortene
INN or Proposed INN: PREDNISONE
Trade Name: Deltacortene
INN or Proposed INN: PREDNISONE
Chiesi Farmaceutici SpANULLNot RecruitingFemale: yes
Male: yes
300Phase 3Belgium;Poland;Spain;Italy
5EUCTR2006-004230-32-IT
(EUCTR)
06/06/200712/11/2007Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETAEfficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA Mild moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: CLIPPER*30CPR 5MG R.M.
INN or Proposed INN: Beclometasone
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
Trade Name: DELTACORTENE FORTE*10CPR 25MG
INN or Proposed INN: Prednisone
CHIESINULLNot RecruitingFemale: yes
Male: yes
300Belgium;Spain;Italy;Poland