Fluimucil ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎7
94原発性硬化性胆管炎1
193プラダー・ウィリ症候群1
298遺伝性膵炎1

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000564-14-GB
(EUCTR)
11/09/201304/07/2013 A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
2EUCTR2012-000564-14-DK
(EUCTR)
28/08/201312/07/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
3EUCTR2012-000564-14-AT
(EUCTR)
19/07/201311/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Sweden;Italy;United Kingdom;Germany;Austria;Denmark;Belgium
4EUCTR2012-000564-14-IT
(EUCTR)
17/07/201307/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
5EUCTR2012-000564-14-DE
(EUCTR)
17/07/201329/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
6EUCTR2012-000564-14-SE
(EUCTR)
25/06/201324/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
7EUCTR2012-000564-14-BE
(EUCTR)
18/06/201330/04/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden

94. 原発性硬化性胆管炎


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-004170-26-IT
(EUCTR)
04/12/201211/10/2012Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis. Chronic pancreatitis and primary sclerosing cholangitis
MedDRA version: 15.0;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0;Classification code 10008609;Term: Cholangitis sclerosing;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: FLUIMUCIL*20CPR EFF 600MG
INN or Proposed INN: ACETYLCYSTEINE
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
200Italy

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000735-61-NL
(EUCTR)
06/04/202104/08/2020Treatment with N-acetylcysteine for skin picking in children and young adults with PWSN- acetylcysteine treatment for skin picking in children and young adults with PWS: a randomized, controlled, cross-over trial. Prader-Willi syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Fluimucil (acetylcysteine)
Product Name: Fluimucil
Product Code: R05CB01
Dutch Growth Research FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 2;Phase 3Netherlands

298. 遺伝性膵炎


臨床試験数 : 98 薬物数 : 180 - (DrugBank : 57) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-004170-26-IT
(EUCTR)
04/12/201211/10/2012Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis. Chronic pancreatitis and primary sclerosing cholangitis
MedDRA version: 15.0;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0;Classification code 10008609;Term: Cholangitis sclerosing;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: FLUIMUCIL*20CPR EFF 600MG
INN or Proposed INN: ACETYLCYSTEINE
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
200Italy