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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 May 2022
• Main ID: NCT01941589
• Date of registration: 30/08/2013
• Prospective Registration: Yes
• Primary sponsor: Sheba Medical Center
• Public title: Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
• Scientific title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
• Date of first enrolment: September 2013
• Target sample size: 149
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01941589
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Ofir Har-Noy, MD
• Affiliation: Sheba Medical Center, Tel-Hashomer, ISRAEL 52621

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: corticosteroids only

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

Primary Outcome(s)

percentage of patients who respond to the treatment [Time Frame: day 7]

Secondary Outcome(s)

colectomy rate [Time Frame: 1 month, 3 months post randomization]

the percentage of patients in need of a rescue medication [Time Frame: day 5, 7]

Secondary ID(s)

SHEBA-13-0401-OH-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors