Baclofen ER Capsules (GRS) 10 mg ( DrugBank: Baclofen )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001356-22-HU
(EUCTR)
13/07/201626/04/2016A STUDY OF THE SAFETY AND EFFECTS OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH TIGHTNESS, STIFFNESS AND PULL OF MUSCLES DUE TO MULTIPLE SCLEROSISA PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS Spasticity due to multiple sclerosis
MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Liofen XL
Product Name: Baclofen ER Capsules (GRS) 10 mg
Product Code: SPARC0921
INN or Proposed INN: BACLOFEN
Trade Name: Baclofen Tablets USP
Product Name: Baclofen Tablets USP 10 mg
INN or Proposed INN: BACLOFEN
Trade Name: Liofen XL
Product Name: Baclofen ER Capsules (GRS) 20 mg
Product Code: SPARC0921
INN or Proposed INN: BACLOFEN
Trade Name: Liofen XL
Product Name: Baclofen ER Capsules (GRS) 30mg
Product Code: SPARC0921
INN or Proposed INN: BACLOFEN
Trade Name: Liofen XL
Product Name: Baclofen ER Capsules (GRS) 40mg
Product Code: SPARC0921
INN or Proposed INN: BACLOFEN
Trade Name: Liofen XL
Product Name: Baclofen ER Capsules (GRS) 50 mg
Product Code: SPARC0921
INN or Proposed INN: BACLOFEN
Sun Pharma Advanced Research Company Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Hungary;Ukraine;Russian Federation;Germany