MD-0901 ( 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5

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 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-JapicCTI-173803
14/3/201808/12/2017Maintenance phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with ulcerative colitis in remission. Ulcerative colitis in remissionIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 40 mg/day are administrated orally once daily after breakfast for 48 weeks.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
MOCHIDA PHARMACEUTICAL CO., LTDNULLcomplete16BOTH26Phase 2-3Japan
2JPRN-JapicCTI-173802
30/1/201808/12/2017Active phase study of MD-0901 in pediatric ulcerative colitis.The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis. Mildly to moderately active ulcerative colitisIntervention name : MD-0901
INN of the intervention : mesalazine
Dosage And administration of the intervention : Mesalazine 80 mg/day are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
MOCHIDA PHARMACEUTICAL CO., LTDNULLcomplete16BOTH26Phase 2-3Japan
3JPRN-JapicCTI-142475
24/12/2013Phase 3 Clinical Trial with MD-0901Phase 3 Clinical Trial with MD-0901 Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Asacol tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH250Phase 3NULL
4JPRN-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
5JPRN-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