Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941589
• Other study ID #: SHEBA-13-0401-OH-CTIL
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: April 2021

Study information

• Verified date: May 2022
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

Description:

he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.

• current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of >10

• age >18

• if taking thiopurines, the dose must be stable for 2 months prior to admission

Exclusion Criteria:

• pregnant women

• allergy/unable to take study medications

• active infection

• severe renal/liver/cardiorespiratory condition

• toxic megacolon or signs of imminent colectomy

• treatment with an anti-tumor necrosis factor in 3 months prior to admission

• prior treatment with cyclosporin or tacrolimus

• alcohol dependancy

• unwilling/ unable to give an informed consent

• participation in clinical trials in the last 2 months prior to admission

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
• corticosteroids only
IV corticosteroids only

Locations

Country	Name	City	State
China	6th affiliated hospital of Sun yat-sen university	Guangzhou
China	Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
France	Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne	Saint-Etienne
Greece	Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou	Heraklion
Greece	Department of Gastroenterology, University Hospital & Medical School of Ionnina	Ioánnina
Israel	Gastroenterology department, Soroka medical center	Be'er Sheva'
Israel	Sheba Medical Center	Tel HaShomer
Italy	Università di Roma Sapienza	Rome
Korea, Republic of	nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine	Seoul
Serbia	Zvezdara University Clinical Center, Gastroenterology Department	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Countries where clinical trial is conducted

China,  France,  Greece,  Israel,  Italy,  Korea, Republic of,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of hospitalization		3-90
Primary	percentage of patients who respond to the treatment		day 7
Secondary	the percentage of patients in need of a rescue medication		day 5, 7
Secondary	colectomy rate		1 month, 3 months post randomization