Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients with Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA).

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524675-23-00

Enrollment

304

Registered

2026-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-30

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

Conditions

Ulcerative Colitis

Brief summary

Biological recurrence: faecal calprotectin >250 µg/g confirmed in two consecutive samples OR clinical recurrence requiring intensification of treatment within 24 months.

Detailed description

Time to relapse, Clinical recurrence rate, Colectomy rate, Safety and adverse events, Mortality, Hospitalisation rate (due to activity or adverse events), Treatment adherence (Morisky-Green scale)

Interventions

DRUGSalofalk 1000 mg granulado de liberación prolongada

DRUGPentasa 4 g granulado de liberación prolongada

DRUGAsacol 1600 mg comprimidos gastrorresistentes

DRUGClaversal 500 mg comprimidos gastrorresistentes

DRUGAsacol 800 mg comprimidos gastrorresistentes

DRUGPENTASA 500 mg comprimidos de liberación prolongada

DRUGPentasa 1g granulado de liberación prolongada

DRUGPentasa 2g granulado de liberación prolongada

DRUGSalofalk 3 g granulado de liberación prolongada

DRUGClaversal 1 g comprimidos gastrorresistentes

DRUGPENTASA1 g comprimidos de liberación prolongada

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Biological recurrence: faecal calprotectin >250 µg/g confirmed in two consecutive samples OR clinical recurrence requiring intensification of treatment within 24 months.	—

Secondary

Measure	Time frame
Time to relapse, Clinical recurrence rate, Colectomy rate, Safety and adverse events, Mortality, Hospitalisation rate (due to activity or adverse events), Treatment adherence (Morisky-Green scale)	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 1, 2026