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EFFICACY OF BECOMETASONE DIPROPIONATE ON MICROSCOPIC COLITIS

EFFICACY OF BECOMETASONE DIPROPIONATE ON MICROSCOPIC COLITIS - EFFICACY OF BECOMETASONE DIPROPIONATE ON MICROSCOPIC COLITIS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017240-14-ES
Enrollment
Unknown
Registered
2012-04-12
Start date
2012-06-21
Completion date
Unknown
Last updated
2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic colitis MedDRA version: 14.1 Level: PT Classification code 10056979 Term: Colitis microscopic System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10048928 Term: Colitis collagenous System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10025268 Term: Lymphocytic colitis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Clipper Product Name: Clipper Product Code: A07E Pharmaceutical Form: Gastro-resistant prolonged-release tablet INN or Proposed INN: BECLOMETASONE DIPROPIONATE CAS Number: 08/09/5534 Curre

Sponsors

ASOCIACIÓN GALLEGA DE ENFERMEDAD INFLAMATORIA INTESTITAL (E.I.G.A.)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the efficacy of beclometasone dipropionate on microscopic colitis during short term follow-up (4 weeks);Secondary Objective: To assess the efficacy of beclometasone dipropionate on microscopic colitis during mid term follow-up (up to one year) To assess the efficacy of beclometasone dipropionate on microscopic colitis recurrences To assess the safety of beclometasone dipropionate on microscopic colitis To assess the efficacy of beclometasone dipropionate on microscopic colitis histologic changes;Primary end point(s): Diarrhea (3 or more depositions per day);Timepoint(s) of evaluation of this end point: 4 weeks 1 year—

Secondary

MeasureTime frame
Secondary end point(s): Faecal incontinence (involuntary faecal depositions) Weight loss (at least 5% of previous weight) Histological healing (dissapearance of histological changes) Histological response (improvement of histological changes without total healing);Timepoint(s) of evaluation of this end point: 4 weeks 1 year—

Countries

Spain

Contacts

Public ContactPEDRO GARCÍA PUIG

FUNDACIÓN INVESTIGACIÓN DESARROLLO E INNOVACION DEL COMPLEJO HOSPITALARIO DE PONTEVEDRA

pedro.garcia.puig@sergas.es34986800924

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026