IPX056 ( DrugBank: - )


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4

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00914290
(ClinicalTrials.gov)
April 20092/6/2009A Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisA Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisSpasticity;Multiple SclerosisDrug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IRImpax Laboratories, LLCNULLCompleted18 YearsN/AAll23Phase 2United States
2EUCTR2007-000236-16-LV
(EUCTR)
04/07/200702/04/2007A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple SclerosisA Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis Established Spasticity Resulting from Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity
Product Code: IPX056-40 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-35 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-30 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-25 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-20 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-10 mg
INN or Proposed INN: BACLOFEN
Trade Name: baclofen
Product Name: baclofen
Product Code: baclofen 20 mg
INN or Proposed INN: BACLOFEN
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Estonia;Latvia
3NCT00488839
(ClinicalTrials.gov)
June 200718/6/2007IPX056 in Subjects With Established Spasticity Resulting From Multiple SclerosisA Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple SclerosisMultiple SclerosisDrug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mgImpax Laboratories, LLCNULLCompleted18 YearsN/AAll173Phase 3United States;Canada;Estonia;Latvia;Ukraine
4EUCTR2007-000236-16-EE
(EUCTR)
28/05/200716/03/2007A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple SclerosisA Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis Established Spasticity Resulting from Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity
Product Code: IPX056-40 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-35 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-30 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-20 mg
INN or Proposed INN: BACLOFEN
Product Code: IPX056-10 mg
INN or Proposed INN: BACLOFEN
Trade Name: baclofen
Product Name: baclofen
Product Code: baclofen 20 mg
INN or Proposed INN: BACLOFEN
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Estonia;Latvia