90 mg idrocortisone acetato in supposta con appli ( 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1

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_
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agemin
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PhaseCountries
1EUCTR2019-003596-19-IT
(EUCTR)
26/06/202017/06/2021A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum.A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. - CESSA Ulcerative Colitis of the Rectum
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure
Product Code: [90 mg idrocortisone acetato in supposta con appli
INN or Proposed INN: IDROCORTISONE ACETATO
Cristcot HCA LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
618Phase 3United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India