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9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01086553
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : October 30, 2014
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Brief Summary:
This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn´s Disease Drug: budesonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease
Study Start Date : November 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: A
9mg budesonide OD
Drug: budesonide
9mg budesonide OD

Active Comparator: B
3mg budesonide TID
Drug: budesonide
3mg budesonide TID

Primary Outcome Measures :
  1. Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points [ Time Frame: 8 weeks ]
  2. Adverse events [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent,
  • Age 18 to 75 years,
  • Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria [endoscopy not older than 12 months or if older, then clinical signs (e.g., pain localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes],
  • Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,
  • Active phase of disease (200 < CDAI < 400),
  • Negative pregnancy test in females of childbearing potential,
  • Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

  • Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms,
  • Septic complications,
  • Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
  • Abscess, perforation, or active fistulas,
  • Ileostomy or colostomy,
  • Resection of more than 50 cm of the ileum,
  • Bowel surgery within the last 3 months,
  • Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
  • Clinical signs of stricturing disease,
  • Subileus within the last 6 months (subileus with inflammatory hint allowed),
  • Suspicion of ileus, subileus or corresponding symptoms,
  • Parenteral or tube feeding,
  • Active peptic ulcer disease, local intestinal infection, or known established cataract,
  • Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured,
  • Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
  • Abnormal renal function (Cystatin C > ULN),
  • Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
  • History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma),
  • Treatment with immunosuppressants or anti-cancer drugs, e.g., 6 TG, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6 MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study,
  • Treatment with ketoconazole or other CYP3A inhibitors within the last month before baseline visit,
  • Treatment with anti-TNF-alpha therapy within 3 months before baseline visit,
  • Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
  • > 6 mg/d budesonide po within 2 weeks before baseline visit,
  • Steroids for inhalation within 2 weeks before baseline visit,
  • Patients known to be steroid-refractory,
  • Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except ≤ 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed),
  • Known intolerance/hypersensitivity to study drug,
  • Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
  • Existing or intended pregnancy or breast-feeding,
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

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 identifier (NCT number): NCT01086553

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Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
Frankfurt, Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Axel Dignass, Prof. Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01086553    
Other Study ID Numbers: BUG-2/CDA
2008-006957-42 ( EudraCT Number )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Dr. Falk Pharma GmbH:
Crohn´s disease
induction of remission
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists