IBD98-M Delayed-release Capsules ( 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2

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
1NCT02493712
(ClinicalTrials.gov)
January 20167/7/2015A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-MA Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: High dose;Drug: Low dose;Drug: PlaceboHoly Stone Healthcare Co., LtdinVentiv Health ClinicalCompleted18 Years75 YearsAll51Phase 2Italy;Taiwan
2EUCTR2015-001022-42-IT
(EUCTR)
01/12/201529/03/2019A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative ColitisA Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis Active, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: IBD98-M Delayed-release Capsules
Product Code: IBD98-M
INN or Proposed INN: SODIUM HYALURONATE
Other descriptive name: SODIUM HYALURONATE
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-ASA
Holy Stone Healthcare Co., Ltd.NULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly