Mesalazine tablet ( DrugBank: Mesalazine )


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8

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
1JPRN-UMIN000026175
2017/06/2301/03/2017Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitisComparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis Ulcerative colitisTime dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .

PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu UniversityNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
2JPRN-JapicCTI-101381
15/11/2010Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase-Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- Ulcerative colitis in remission phaseIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d are administrated orally once daily after breakfast for 48 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25g/d are administrated orally 3 times daily after each meal for 48 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH190Phase 3NULL
3JPRN-JapicCTI-101380
15/11/2010Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis-Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 2.4 g/d or 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Mesalazine tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 2.25 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH228Phase 3NULL
4EUCTR2009-011608-51-DE
(EUCTR)
09/10/200921/07/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
5EUCTR2009-011608-51-SE
(EUCTR)
17/08/200922/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
6EUCTR2009-011608-51-BE
(EUCTR)
03/08/200923/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belgium;Germany;Sweden
7EUCTR2008-007292-25-IT
(EUCTR)
24/03/200916/03/2009AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
8JPRN-JapicCTI-101144
25/05/2010Phase II/III induction study of AJG501 in patients with active ulcerative colitisPhase II/III induction study of AJG501 in patients with active ulcerative colitis Ulcerative colitisIntervention name : AJG501
Dosage And administration of the intervention : oral
Control intervention name : Mesalazine tablet
Dosage And administration of the control intervention : oral
Ajinomoto Pharmaceuticals Co., Ltd.NULL1664BOTHPhase 2-3NULL