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EFFICACY OF BECOMETASONE DIPROPIONATE ON MICROSCOPIC COLITIS

Conditions
Microscopic colitis
MedDRA version: 14.1Level: PTClassification code 10056979Term: Colitis microscopicSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10025268Term: Lymphocytic colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Registration Number
EUCTR2009-017240-14-ES
Lead Sponsor
ASOCIACIÓN GALLEGA DE ENFERMEDAD INFLAMATORIA INTESTITAL (E.I.G.A.)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients diagnosed of microscopic colitis (either lymphocitic or collagenous)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age under 18
Pregnancy or lactancy
Either allergy or intolerance to the substance
Corticosteroids treatment contra-indications
Other causes of diarrhea

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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