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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 : Recruiting
First Posted : September 13, 2013
Last Update Posted : October 24, 2017
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018


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 ]


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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


Contacts
Contact: Ofir Har-Noy, MD +972-3-530-2679 ofirharnoy@gmail.com
Contact: Shomron Ben-Horin, MD +972-3-530-2679 sben-horin@013net.net

Locations
China
6th affiliated hospital of Sun yat-sen university Recruiting
Guangzhou, China
Contact: Jian Tang, MD         
Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Mao Ren, MD, PhD         
France
Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne Recruiting
Saint-Etienne, France
Contact: Xavier Roblin, MD, PhD         
Greece
Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou Recruiting
Heraklion, Greece
Contact: Konstantinos Karmiris, MD, PhD         
Department of Gastroenterology, University Hospital & Medical School of Ionnina Recruiting
Ioánnina, Greece
Contact: Konstantinos Katsanos, MD PHD         
Israel
Gastroenterology department, Soroka medical center Recruiting
Be'er Sheva`, Israel
Contact: Doron schwartz, MD         
Sheba Medical Center Recruiting
Tel HaShomer, Israel, 52621
Contact: Ofir Har-Noy, MD    +972-3-530-2679    ofirharnoy@gmail.com   
Principal Investigator: Ofir Har-Noy, MD         
Italy
Università di Roma Sapienza Recruiting
Rome, Italy
Contact: Monica Cesarini, MD         
Korea, Republic of
nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Jae-Hee Cheon, MD PHD         
Serbia
Zvezdara University Clinical Center, Gastroenterology Department Recruiting
Belgrade, Serbia
Contact: Marijana Protic, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ofir Har-Noy, MD Sheba Medical Center, Tel-Hashomer, ISRAEL 52621

Responsible Party: Dr. Ofir Harnoy MD, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01941589     History of Changes
Other Study ID Numbers: SHEBA-13-0401-OH-CTIL
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Prednisolone acetate
Methylprednisolone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Hydrocortisone
Mesalamine
Prednisolone hemisuccinate
Prednisolone phosphate
Aminosalicylic Acid
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids