GM-CSF, fosfomycin and metronidazole ( DrugBank: Fosfomycin, Metronidazole )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎2

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04979832
(ClinicalTrials.gov)
September 6, 202130/6/2021GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA SurgeryA Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis SurgeryPouchitisDrug: GM-CSF, fosfomycin and metronidazoleZealand University HospitalNULLRecruiting18 YearsN/AAll18Phase 1/Phase 2Denmark
2EUCTR2020-000609-10-DK
(EUCTR)
06/07/202123/09/2020A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patientsA combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Repomol
INN or Proposed INN: Molgramostim
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole
Trade Name: Fosfomycin
Product Name: Infectofos
INN or Proposed INN: Fosfomycin disodium
Other descriptive name: FOSFOMYCIN DISODIUM
Center for Surgical ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 1;Phase 2Denmark