Inflammatory Bowel Disease (IBD)NCT00152620
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
A study testing Dexamethasone and Methylprednisolone in people with Inflammatory Bowel Disease (IBD), run by University of Chicago at 1 site in United States.
Trial summary
The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone. Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Dexamethasone and Methylprednisolone
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parental informed consent
- Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of >10.
- Infectious causes (viruses, bacteria, parasites) have been ruled out.
Who cannot join
- Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens.
- Subjects with enterostomy or colostomy
- Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637
About this study
The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Dexamethasone, Methylprednisolone
- Keywords
- Inflammatory Bowel Disease (IBD)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Crohn's Disease Activity Index (PCDAI)
Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
Secondary outcomes (1)
Partial Harvey Bradshaw score (pHB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJun 2004
- Study completionMay 2007
Why it stopped: study completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara S Kirschner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152620
- Sponsor's protocol ID
- 13171B
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
Publications
EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5(1):1-22. doi: 10.1136/gut.5.1.1. No abstract available.
PubMed 14127503Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.
PubMed 4149894Boumpas DT, Paliogianni F, Anastassiou ED, Balow JE. Glucocorticosteroid action on the immune system: molecular and cellular aspects. Clin Exp Rheumatol. 1991 Jul-Aug;9(4):413-23.
PubMed 1934694Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. doi: 10.1016/0165-6147(93)90184-l.
PubMed 7510080Chun A, Chadi RM, Korelitz BI, Colonna T, Felder JB, Jackson MH, Morgenstern EH, Rubin SD, Sacknoff AG, Gleim GM. Intravenous corticotrophin vs. hydrocortisone in the treatment of hospitalized patients with Crohn's disease: a randomized double-blind study and follow-up. Inflamm Bowel Dis. 1998 Aug;4(3):177-81. doi: 10.1097/00054725-199808000-00001.
PubMed 9741018Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. doi: 10.1016/s0140-6736(74)90552-2. No abstract available.
PubMed 4135487Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. doi: 10.1016/s0889-8553(05)70058-3.
PubMed 10372270Meyers S, Lerer PK, Feuer EJ, Johnson JW, Janowitz HD. Predicting the outcome of corticoid therapy for acute ulcerative colitis. Results of a prospective, randomized, double-blind clinical trial. J Clin Gastroenterol. 1987 Feb;9(1):50-4. doi: 10.1097/00004836-198702000-00013.
PubMed 3031150Kaplan HP, Portnoy B, Binder HJ, Amatruda T, Spiro H. A controlled evaluation of intravenous adrenocorticotropic hormone and hydrocortisone in the treatment of acute colitis. Gastroenterology. 1975 Jul;69(1):91-5.
PubMed 168121Panes J, Esteve M, Cabre E, Hinojosa J, Andreu M, Sans M, Fernandez-Banares F, Feu F, Gassull MA, Pique JM. Comparison of heparin and steroids in the treatment of moderate and severe ulcerative colitis. Gastroenterology. 2000 Oct;119(4):903-8. doi: 10.1053/gast.2000.18159.
PubMed 11040177Sood A, Midha V, Sood N, Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31. doi: 10.1097/00004836-200210000-00009.
PubMed 12352296Mager DE, Lin SX, Blum RA, Lates CD, Jusko WJ. Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics. J Clin Pharmacol. 2003 Nov;43(11):1216-27. doi: 10.1177/0091270003258651.
PubMed 14551176Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3(Suppl 3):III43-6. doi: 10.1136/gut.50.suppl_3.iii43.
PubMed 11953332
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00152620
- Acronym / sponsor ID
- 13171B
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Inflammatory Bowel Disease (IBD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study completed
- Enrolment
- 40 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- May 2007 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parental informed consent
- Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of >10.
- Infectious causes (viruses, bacteria, parasites) have been ruled out.
Key exclusion criteria (3 listed)
- Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens.
- Subjects with enterostomy or colostomy
- Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | – |
| Methylprednisolone | Drug | – |
Primary outcome
Pediatric Crohn's Disease Activity Index (PCDAI)
Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
1 secondary outcome
Partial Harvey Bradshaw score (pHB)
Results and safety
The study was stopped early (reason given: study completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Background: PubMed 14127503EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5(1):1-22. doi: 10.1136/gut.5.1.1. No abstract available.
- Background: PubMed 4149894Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.
- Background: PubMed 1934694Boumpas DT, Paliogianni F, Anastassiou ED, Balow JE. Glucocorticosteroid action on the immune system: molecular and cellular aspects. Clin Exp Rheumatol. 1991 Jul-Aug;9(4):413-23.
- Background: PubMed 7510080Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. doi: 10.1016/0165-6147(93)90184-l.
- Background: PubMed 9741018Chun A, Chadi RM, Korelitz BI, Colonna T, Felder JB, Jackson MH, Morgenstern EH, Rubin SD, Sacknoff AG, Gleim GM. Intravenous corticotrophin vs. hydrocortisone in the treatment of hospitalized patients with Crohn's disease: a randomized double-blind study and follow-up. Inflamm Bowel Dis. 1998 Aug;4(3):177-81. doi: 10.1097/00054725-199808000-00001.
- Background: PubMed 4135487Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. doi: 10.1016/s0140-6736(74)90552-2. No abstract available.
- Background: PubMed 10372270Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. doi: 10.1016/s0889-8553(05)70058-3.
- Background: PubMed 3031150Meyers S, Lerer PK, Feuer EJ, Johnson JW, Janowitz HD. Predicting the outcome of corticoid therapy for acute ulcerative colitis. Results of a prospective, randomized, double-blind clinical trial. J Clin Gastroenterol. 1987 Feb;9(1):50-4. doi: 10.1097/00004836-198702000-00013.
- Background: PubMed 168121Kaplan HP, Portnoy B, Binder HJ, Amatruda T, Spiro H. A controlled evaluation of intravenous adrenocorticotropic hormone and hydrocortisone in the treatment of acute colitis. Gastroenterology. 1975 Jul;69(1):91-5.
- Background: PubMed 11040177Panes J, Esteve M, Cabre E, Hinojosa J, Andreu M, Sans M, Fernandez-Banares F, Feu F, Gassull MA, Pique JM. Comparison of heparin and steroids in the treatment of moderate and severe ulcerative colitis. Gastroenterology. 2000 Oct;119(4):903-8. doi: 10.1053/gast.2000.18159.
- Background: PubMed 12352296Sood A, Midha V, Sood N, Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31. doi: 10.1097/00004836-200210000-00009.
- Background: PubMed 14551176Mager DE, Lin SX, Blum RA, Lates CD, Jusko WJ. Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics. J Clin Pharmacol. 2003 Nov;43(11):1216-27. doi: 10.1177/0091270003258651.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara S Kirschner, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Methylprednisolone in people with Inflammatory Bowel Disease (IBD), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Crohn's Disease Activity Index (PCDAI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00152620, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.