97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


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

  
15 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2019-003596-19-RO
(EUCTR)
07/07/202121/04/2022A 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
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
3EUCTR2019-003596-19-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
4EUCTR2011-002462-20-SK
(EUCTR)
19/11/201227/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Hungary;Czech Republic;Slovakia;Poland;Germany;Italy
5EUCTR2011-002462-20-IT
(EUCTR)
02/01/201208/03/2012Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study mild to moderate ulcerative colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Lysine-D-proline-threonine
Product Code: K(D)PT
INN or Proposed INN: NA
Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate
DR. AUGUST WOLFF GMBH & CO. KGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Czech Republic;Slovakia;Poland;Germany;Italy
6EUCTR2011-002462-20-PL
(EUCTR)
27/12/201120/10/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Czech Republic;Poland;Germany;Italy
7EUCTR2011-002462-20-HU
(EUCTR)
07/12/201122/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Czech Republic;Hungary;Poland;Germany;Italy
8EUCTR2011-002462-20-CZ
(EUCTR)
24/11/201120/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Hungary;Czech Republic;Poland;Germany;Italy
9EUCTR2011-002462-20-DE
(EUCTR)
25/10/201113/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Czech Republic;Poland;Germany;Italy
10EUCTR2007-002542-38-DK
(EUCTR)
28/11/200708/11/2007A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitisA randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210 Ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Sotrastaurin
Product Code: AEB071
INN or Proposed INN: Sotrastaurin (INN) acetate
Product Name: Vitamin B2
INN or Proposed INN: Riboflavin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark;Germany
11EUCTR2004-004077-29-SK
(EUCTR)
25/04/200501/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Slovakia;Lithuania;Germany;United Kingdom
12EUCTR2004-004077-29-GB
(EUCTR)
18/02/200523/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble Technical Centres LtdNULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Lithuania;Germany;United Kingdom
13EUCTR2004-004077-29-LT
(EUCTR)
09/02/200522/12/2004A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Czech Republic;Germany;Lithuania
14EUCTR2004-004077-29-DE
(EUCTR)
04/02/200522/12/2004A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Czech Republic;Germany;Lithuania
15EUCTR2004-004077-29-CZ
(EUCTR)
03/02/200503/02/2005A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative ColitisA Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Product Name: RDP58
Product Code: RDP58
INN or Proposed INN: Delmitide acetate
Other descriptive name: SF257 C59
Product Name: mesalazine
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic Acid
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Czech Republic;Lithuania