Tranilast ( DrugBank: Tranilast )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ7
84サルコイドーシス1
106クリオピリン関連周期熱症候群1
113筋ジストロフィー3

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-006917-25-PL
(EUCTR)
24/06/200910/03/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
2EUCTR2008-006917-25-BG
(EUCTR)
09/06/200910/06/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
3EUCTR2008-006917-25-CZ
(EUCTR)
22/05/200911/03/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Poland;Bulgaria;Germany;United Kingdom
4EUCTR2008-006917-25-DE
(EUCTR)
24/04/200922/01/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). Patients with active rheumatoid arthritis who are on a stable dose of methotrexateTrade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Trade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Czech Republic;Germany;Bulgaria;Poland
5EUCTR2008-006917-25-GB
(EUCTR)
22/04/200909/04/2009A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RAA Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA Patients with active rheumatoid arthritis who are on a stable dose of methotrexateProduct Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
Nuon Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Germany;United Kingdom;Bulgaria;Poland
6NCT00882024
(ClinicalTrials.gov)
March 200914/4/2009Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)Active Rheumatoid ArthritisDrug: Tranilast;Drug: PlaceboNuon Therapeutics, Inc.NULLCompleted18 Years75 YearsBoth250Phase 2United States;Argentina;Bulgaria;Czech Republic;Germany;Mexico;Serbia;United Kingdom
7NCT00717808
(ClinicalTrials.gov)
September 200814/7/2008Effects of Tranilast on Pharmacokinetics of Methotrexate (MTX) in Patients With Rheumatoid Arthritis (RA)A Phase 1, Blinded, Randomised, Crossover Pilot Study to Investigate the Safety, Tolerability and Pharmacokinetics of Tranilast in Patients With Rheumatoid Arthritis on MethotrexateRheumatoid ArthritisDrug: Tranilast;Drug: Placebo comparatorImperial College LondonNuon Therapeutics, Inc.Withdrawn18 Years75 YearsBoth0Phase 1United Kingdom

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03528070
(ClinicalTrials.gov)
May 201819/4/2018A Clinical Study of Tranilast in the Treatment of SarcoidosisA Clinical Study of Tranilast in the Treatment of SarcoidosisSarcoidosisDrug: TranilastThe First Affiliated Hospital with Nanjing Medical UniversityNULLUnknown status18 YearsN/AAll56Early Phase 1NULL

106. クリオピリン関連周期熱症候群


臨床試験数 : 42 薬物数 : 24 - (DrugBank : 4) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03923140
(ClinicalTrials.gov)
May 23, 201914/4/2019A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)Efficacy and Safety of Tranilast in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS): A Single-Arm Prospective Cohort StudyCryopyrin-Associated Periodic SyndromesDrug: TranilastPeking Union Medical College HospitalNULLRecruitingN/AN/AAll71Phase 2China

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180038
18/12/201812/11/2018Tranilast-MDA multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy - Tranilast-MD muscular dystrophy
muscular dystrophy ,heart failure ,tranilast;muscular dystrophies
Tranilast 300 mg / day is administered three times per minute.
Treatment for 28 weeks (in principle, outpatient administration). As of the 28th week, reconfirmation of consent regarding continuation of administration is confirmed, and if confirmation is obtained, further treatment for 116 weeks is carried out.
Matsumura TsuyoshiNULLNot Recruiting>= 13age oldNot applicableBoth20N/AJapan
2JPRN-UMIN000031965
2018/12/1430/03/2018A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophyA multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophy - Tranilast-MD Heart failure patients with muscular dystrophy who showed brain natriuretic peptide (BNP) of 100 pg/mL or more in spite of myocardial protection treatmentTranilast 300 mg/day is administered three times per day as the study treatment.
The start date of study treatment is defined as the medication start date, and 28 weeks of study treatment will be performed (in principle, by outpatient administration). We reconfirm consent for continuation of administration at 28 weeks, and if consent is obtained, further treatment for 116 weeks will be carried out.
As long as there are no particular problems, the outpatient visit during the observation period is in 4 weeks (21-35 days), 12 weeks (77-91 days), 20 weeks (134-147 days), 24 weeks (161-175 days), and 28 weeks (190-203 days) after starting medication. A prescription until the next outpatient visit will be issued at the consultation. The outpatient visit after consent reconfirmation is done at 12-weeks intervals after 36 weeks, and the prescription until the next outpatient visit will be issued until the next 144 weeks after starting medication at the consultation.
Evaluation of various examination findings including clinical findings, cardiac functions, respiratory functions, motor function, QOL Questionnaire (MDQoL-60, SF-12), and adverse events at the designated timing.
In order to confirm TRPV2 inhibitory effect by tranilast and to assess its effectiveness as a biomarker, central laboratory tests for the TRPV2 expression analysis will be performed.
National Hospital Organization Toneyama National HospitalNULLComplete: follow-up continuing13years-oldNot applicableMale and Female20Not selectedJapan
3JPRN-UMIN000020580
2016/01/1520/01/2016Pilot study of tranilast for cardiomyopathy of muscular dystrophyPilot study of tranilast for cardiomyopathy of muscular dystrophy - Pilot study of tranilast for cardiomyopathy of muscular dystrophy muscular dystrophyTranilast 300mg/day for three months (oral intake)National Hospital Organization Toneyama National HospitalNational Cerebral and Cardiovascular CenterComplete: follow-up complete20years-oldNot applicableMale and Female2Not applicableJapan