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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-001216-31-SI
(EUCTR)
22/12/200526/10/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany
2EUCTR2004-001216-31-CZ
(EUCTR)
17/08/200517/08/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania
3EUCTR2004-001216-31-SK
(EUCTR)
28/07/200523/05/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Phase 3Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
4EUCTR2004-001216-31-HU
(EUCTR)
28/07/200520/06/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
5EUCTR2004-001216-31-LV
(EUCTR)
25/07/200525/07/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
6EUCTR2004-001216-31-LT
(EUCTR)
06/06/200528/04/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
7EUCTR2004-001216-31-DE
(EUCTR)
30/05/200504/04/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
8EUCTR2004-001216-31-EE
(EUCTR)
11/01/200520/09/2005Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UCDouble-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC Therapy of active ulcerative colitis
MedDRA version: 7.1;Level: LLT;Classification code 10058816
Trade Name: Salofalk® 1000mg Granu-Stix®
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 1500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 500mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
320Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania