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Clinical Trials in Italy / NCT03261206
Active, not recruiting Phase 4

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

NCT03261206 · tracked via the Priya Life Science Italy tracker
Phase
Phase 4
Started
2017-11-20
Last updated
2026-05-28

Condition(s) studied

Crohn DiseaseRemission

Investigational drug(s) / intervention(s)

5-ASA Withdrawal

5-ASA Withdrawal: Withdrawal of 5-ASA therapy

Study summary

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documented diagnosis of CD at least 3 months prior to enrollment * Taking any brand or dosage of an oral aminosalicylate for at least 6 months * Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses) * CD currently in clinical remission * Able to participate fully in all aspects of the clinical trial * Written informed consent obtained and documented Exclusion Criteria: * A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis * A diagnosis of short-bowel syndrome * Active perianal disease * Active fistulizing disease * A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery * Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment * Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment * Unwillingness to stop taking aminosalicylates for the duration of the trial * Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment * Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study * History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures * Currently participating in another interventional trial, or previous participation within the last 3 months

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
University of Calgary Calgary Alberta
University of Alberta Edmonton Alberta
Dr. Jesse Siffledeen Professional Medical Corporation Edmonton Alberta
(G.I.R.I.) GI Research Institute Vancouver British Columbia
Discovery Clinical Services Ltd. Victoria British Columbia
University of Manitoba - Health Sciences Centre Winnipeg Manitoba
London Health Sciences Centre - University Hospital London Ontario
Scott Shulman Medical Professional Corporation North Bay Ontario
Taunton Surgical Center Oshawa Ontario
Mount Sinai Hospital Toronto Ontario
Dr. O. Tarabain Medicine Professional Corporation Windsor Ontario
McGill University Healthcare Montreal Quebec
IRCCS Policlinico San Donato San Donato Milanese Milan Italy
Ospedale San Raffaele S.r.I. Milan Milan
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali Roma Rome
IRCCS De Bellis Castellana Grotte Via Turi
Luigi Vanvitelli of Campania Catania Italy
Intituto Clinico Humanitas Milan Italy
Azienda Ospedale-Universita Padova Padova Italy
Campus Bio-Medico University of Rome Roma Italy
BYK - Kyiv Kyiv Ukraine
Danylo Halytsky Lviv National Medical University Lviv Ukraine
Odesa Regional Clinical Hospital Odesa Ukraine
Ternopil University Hospital Ternopil Ukraine
Warrington and Halton Hospitals NHS Foundation Trust Warrington Cheshire
Darlington Memorial Hospital Darlington Durham
Basildon and Thurrock University Hospitals NHS Foundation Trust Basildon Essex
Royal Blackburn Hospital Blackburn Lancashire
St. Marks Hospital Harrow Middlesex
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital Sutton in Ashfield Nottinghamshire
Barnsley Hospital NHS Trust Barnsley Yorkshire
Bedford Hospital NHS Trust Bedford United Kingdom
Southmead Hospital, North Bristol NHS Trust Bristol United Kingdom
Northern Care Alliance NHS Group - Fairfield General Hospital Bury United Kingdom
West Suffolk Hospital Bury St Edmunds United Kingdom
ESNEFT Colchester Gen Hospital Colchester United Kingdom
Dudley Group NHS Foundation Trust Dudley United Kingdom
Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary Leicester United Kingdom
Royal Free Hospital London United Kingdom

+ 6 more sites — see the full list on the official registry below.

More Alimentiv Inc. trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03261206 on ClinicalTrials.gov ↗ ← All trials in Italy