Hydrocortisone acetate    (DrugBank: Hydrocortisone, Acetate, Hydrocortisone acetate)

1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis2

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 2,269 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1NCT04469686
(ClinicalTrials.gov)
July 30, 20202/7/2020Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative ColitisUlcerative ProctitisCombination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicatorCristcot LLCCristcot HCA LLCRecruiting18 YearsN/AAll618Phase 3United States
2EUCTR2019-003596-19-DE
(EUCTR)
29/07/202029/07/2020A 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 with Ulcerative 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 with Ulcerative 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 hydrocortisone acetate suppository with Sephure suppository applicator
INN or Proposed INN: HYDROCORTISONE ACETATE
Cristcot HCA LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
618Phase 3United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India