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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
corticosteroids only
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 6th affiliated hospital of Sun yat-sen university
  • Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
  • Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
  • Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
  • Department of Gastroenterology, University Hospital & Medical School of Ionnina
  • Gastroenterology department, Soroka medical center
  • Sheba Medical Center
  • Università di Roma Sapienza
  • nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
  • Zvezdara University Clinical Center, Gastroenterology Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

present 5-ASA arm 1

5-ASA naive arm 1

present 5-ASA arm 2

5-ASA naive arm 2

Arm Description

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

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

IV corticosteroids only / PO Methylprednisolone

IV corticosteroids only / PO Methylprednisolone

Outcomes

Primary Outcome Measures

percentage of patients who respond to the treatment

Secondary Outcome Measures

the percentage of patients in need of a rescue medication
colectomy rate

Full Information

First Posted
August 30, 2013
Last Updated
May 6, 2022
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01941589
Brief Title
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
Official Title
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
present 5-ASA arm 1
Arm Type
Active Comparator
Arm Description
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
Arm Title
5-ASA naive arm 1
Arm Type
Active Comparator
Arm Description
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
Arm Title
present 5-ASA arm 2
Arm Type
Active Comparator
Arm Description
IV corticosteroids only / PO Methylprednisolone
Arm Title
5-ASA naive arm 2
Arm Type
Active Comparator
Arm Description
IV corticosteroids only / PO Methylprednisolone
Intervention Type
Drug
Intervention Name(s)
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
Other Intervention Name(s)
rafassal, pentasa, asacol, hydrocortisone, solu-cortef, methylprednisolone
Intervention Description
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
Intervention Type
Drug
Intervention Name(s)
corticosteroids only
Other Intervention Name(s)
hydrocortisone, solu-cortef, methylprednisolone
Intervention Description
IV corticosteroids only
Primary Outcome Measure Information:
Title
percentage of patients who respond to the treatment
Time Frame
day 7
Secondary Outcome Measure Information:
Title
the percentage of patients in need of a rescue medication
Time Frame
day 5, 7
Title
colectomy rate
Time Frame
1 month, 3 months post randomization
Other Pre-specified Outcome Measures:
Title
duration of hospitalization
Time Frame
3-90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Har-Noy, MD
Organizational Affiliation
Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
Official's Role
Principal Investigator
Facility Information:
Facility Name
6th affiliated hospital of Sun yat-sen university
City
Guangzhou
Country
China
Facility Name
Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
City
Saint-Etienne
Country
France
Facility Name
Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
City
Heraklion
Country
Greece
Facility Name
Department of Gastroenterology, University Hospital & Medical School of Ionnina
City
Ioánnina
Country
Greece
Facility Name
Gastroenterology department, Soroka medical center
City
Be'er Sheva'
Country
Israel
Facility Name
Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Università di Roma Sapienza
City
Rome
Country
Italy
Facility Name
nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Zvezdara University Clinical Center, Gastroenterology Department
City
Belgrade
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35272029
Citation
Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1. doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8.
Results Reference
derived

Learn more about this trial

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

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