EUCTR2019-003596-19-RO进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 618
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating females aged 18 years and older.
- •Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2.
- •Modified Mayo sub-score for stool frequency of 1-3.
- •Modified Mayo sub-score for rectal bleeding of 0-2.
- •Modified Mayo endoscopic sub-score of 2-3.
- •Total Modified Mayo Score (without physician global assessment) of 3-8.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 587
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and radiation-proctitis, Crohn’s disease, collagenous colitis and indeterminate colitis.
- •Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
- •Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
- •Bleeding hemorrhoids at the time of enrollment.
- •Acute diverticulitis at the time of enrollment.
- •Acute or chronic pancreatitis at the time of enrollment.
- •Unmanaged celiac disease at the time of enrollment.
- •Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
研究者
相似试验
进行中（未招募）
1 期
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.lcerative Colitis of the RectumMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: HLTClassification code 10027682Term: Immune and associated conditions NECSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: HLGTClassification code 10027665Term: Immune disorders NECSystem Organ Class: 10021428 - Immune system disordersEUCTR2019-003596-19-ITCristcot HCA LLC618
招募中
1 期
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.EUCTR2019-003596-19-DKCristcot HCA LLC199
招募中
3 期
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 RectumSubjects with Ulcerative Colitis of the RectumUlcerative Colitis of the RectumK51.2LBCTR2024015424Cristcot HCA LLC189
招募中
3 期
Study to evaluate safety and efficacy of Novel Hydrocortisone Acetate 90 mg in Subjects with Ulcerative Colitis of the Rectum CHS1221CTRI/2020/09/028172Cristcot HCA LLC
进行中（未招募）
1 期
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.EUCTR2019-003596-19-DECristcot HCA LLC618