Alginate ( DrugBank: alginate )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
53シェーグレン症候群1
299嚢胞性線維症15

53. シェーグレン症候群


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000029307
2009/02/0127/09/2017Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients Sjogren's syndromePilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.Teikyo UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female50Not selectedJapan

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 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
1EUCTR2018-000378-30-DE
(EUCTR)
04/03/202006/06/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
2EUCTR2018-000378-30-GB
(EUCTR)
03/03/202026/06/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20 - 17.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 27.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 37.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
3EUCTR2018-000378-30-AT
(EUCTR)
04/11/201905/07/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
4NCT03822455
(ClinicalTrials.gov)
May 16, 201929/1/2019A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic FibrosisA Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: OligoG DPIAlgiPharma ASAlgiPharma Australia Pty. Ltd.Active, not recruiting18 YearsN/AAll20Phase 2Australia
5NCT02453789
(ClinicalTrials.gov)
February 201514/5/2015A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. InfectionA Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.Cystic Fibrosis;Burkholderia InfectionDrug: Alginate oligosaccharide;Drug: PlaceboAlgiPharma ASNULLCompleted18 YearsN/AAll15Phase 2Germany
6EUCTR2014-002125-35-DE
(EUCTR)
18/12/201421/07/2014A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Germany
7EUCTR2014-000844-13-SE
(EUCTR)
21/10/201421/07/2014A phase IIb study of OligoG in subjects with cystic fibrosisA double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
76Phase 2Denmark;Germany;Sweden
8NCT02157922
(ClinicalTrials.gov)
October 20144/6/2014A Phase IIb Study of OligoG in Subjects With Cystic FibrosisA Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic FibrosisCystic FibrosisDrug: alginate oligosaccharideAlgiPharma ASEurostars;Smerud Medical Research International ASCompleted18 YearsN/AAll65Phase 2Denmark;Germany;Norway;Sweden;United Kingdom
9EUCTR2014-000844-13-DK
(EUCTR)
25/09/201408/07/2014A phase IIb study of OligoG in subjects with cystic fibrosisA double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
76Phase 2Denmark;Germany;Sweden
10NCT01465529
(ClinicalTrials.gov)
May 201131/10/2011A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. FibrosisA Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas AeruginosaCystic FibrosisDrug: OligoG CF-5/20;Drug: SalineAlgiPharma ASNULLCompleted18 YearsN/ABoth26Phase 1/Phase 2Ireland;United Kingdom
11EUCTR2010-023090-19-IE
(EUCTR)
08/04/201115/02/2011A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosaA double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: OligoG (60 mg/ml)
Product Code: OligoG
INN or Proposed INN: Sodium alginate
Other descriptive name: SODIUM ALGINATE
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Ireland;United Kingdom
12EUCTR2010-023090-19-GB
(EUCTR)
29/03/201111/02/2011A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosaA double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: OligoG (60 mg/ml)
Product Code: OligoG
INN or Proposed INN: OligoG
Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Ireland;United Kingdom
13NCT00970346
(ClinicalTrials.gov)
September 20091/9/2009Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic FibrosisA Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy VolunteersCystic FibrosisDrug: OligoG CF-5/20AlgiPharma ASSmerud Medical Research International ASCompleted18 Years65 YearsMale26Phase 1United Kingdom
14EUCTR2018-000378-30-PL
(EUCTR)
01/06/2020A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNAFemale: yes
Male: yes
180Phase 2Poland;Ireland;Austria;Germany;United Kingdom
15EUCTR2018-000378-30-IE
(EUCTR)
26/06/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20 - 17.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 27.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 37.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom