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

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ClinicalTrials.gov Identifier: NCT01941589
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Ofir Harnoy MD, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone Drug: corticosteroids only Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
Study Start Date : September 2013
Actual Primary Completion Date : April 2021
Actual Study Completion Date : April 2021


Arm Intervention/treatment
Active Comparator: present 5-ASA arm 1
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
Other Names:
  • rafassal
  • pentasa
  • asacol
  • hydrocortisone
  • solu-cortef
  • methylprednisolone

Active Comparator: 5-ASA naive arm 1
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
Other Names:
  • rafassal
  • pentasa
  • asacol
  • hydrocortisone
  • solu-cortef
  • methylprednisolone

Active Comparator: present 5-ASA arm 2
IV corticosteroids only / PO Methylprednisolone
Drug: corticosteroids only
IV corticosteroids only
Other Names:
  • hydrocortisone
  • solu-cortef
  • methylprednisolone

Active Comparator: 5-ASA naive arm 2
IV corticosteroids only / PO Methylprednisolone
Drug: corticosteroids only
IV corticosteroids only
Other Names:
  • hydrocortisone
  • solu-cortef
  • methylprednisolone




Primary Outcome Measures :
  1. percentage of patients who respond to the treatment [ Time Frame: day 7 ]

Secondary Outcome Measures :
  1. the percentage of patients in need of a rescue medication [ Time Frame: day 5, 7 ]
  2. colectomy rate [ Time Frame: 1 month, 3 months post randomization ]

Other Outcome Measures:
  1. duration of hospitalization [ Time Frame: 3-90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941589


Locations
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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, China
France
Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, France
Greece
Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
Heraklion, Greece
Department of Gastroenterology, University Hospital & Medical School of Ionnina
Ioánnina, Greece
Israel
Gastroenterology department, Soroka medical center
Be'er Sheva', Israel
Sheba Medical Center
Tel HaShomer, Israel, 52621
Italy
Università di Roma Sapienza
Rome, Italy
Korea, Republic of
nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of
Serbia
Zvezdara University Clinical Center, Gastroenterology Department
Belgrade, Serbia
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ofir Har-Noy, MD Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ofir Harnoy MD, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01941589    
Other Study ID Numbers: SHEBA-13-0401-OH-CTIL
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists