Salofalk® 500mg ( 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7

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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-007928-18-DE
(EUCTR)
04/06/200812/11/2008Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCUEvaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU ulcerative colitis patients in clinical remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Myrrhinil-Intest®
INN or Proposed INN: MATRICARIA FLOWER
Other descriptive name: MATRICARIA FLOWER
INN or Proposed INN: MYRRH
Other descriptive name: MYRRH
INN or Proposed INN: COFFEE COAL
Other descriptive name: COFFEE COAL
Trade Name: Salofalk® 500mg
INN or Proposed INN: MESALAZINE
REPHA GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 4Germany
2EUCTR2004-001218-15-SI
(EUCTR)
22/12/200526/10/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Estonia;Hungary;Slovenia;Lithuania;Latvia;Germany
3EUCTR2004-001218-15-EE
(EUCTR)
07/06/200527/04/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Estonia;Latvia;Lithuania
4EUCTR2004-001218-15-LV
(EUCTR)
30/05/200530/05/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Germany;Estonia;Latvia;Lithuania
5EUCTR2004-001218-15-SK
(EUCTR)
24/03/200502/02/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Estonia;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
6EUCTR2004-001218-15-HU
(EUCTR)
17/03/200504/02/2005Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Germany;Estonia;Latvia;Lithuania
7EUCTR2004-001218-15-LT
(EUCTR)
09/02/200527/12/2004Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UCDouble-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC Maintenance therapy of ulcerative colitisTrade Name: Salofalk® 500mg 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: 750mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Product Name: 250mg mesalazine pellets
INN or Proposed INN: Mesalazine
Other descriptive name: 5-Aminosalicylic acid
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Estonia;Latvia;Lithuania