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

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ClinicalTrials.gov Identifier: NCT01086553
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
  • Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points [ Time Frame: 8 weeks ]
  • Adverse events [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn´s Disease
Intervention  ICMJE
  • Drug: budesonide
    9mg budesonide OD
  • Drug: budesonide
    3mg budesonide TID
Study Arms  ICMJE
  • Experimental: A
    9mg budesonide OD
    Intervention: Drug: budesonide
  • Active Comparator: B
    3mg budesonide TID
    Intervention: Drug: budesonide
Publications * Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsová E, Altorjay I, Tuculanu D, Bunganič I, Pokrotnieks J, Kupčinskas L, Dilger K, Greinwald R, Mueller R; International Budenofalk Study Group. Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2014 Sep;8(9):970-80. doi: 10.1016/j.crohns.2014.01.021. Epub 2014 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2014)
471
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
400
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01086553
Other Study ID Numbers  ICMJE BUG-2/CDA
2008-006957-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Falk Pharma GmbH
Study Sponsor  ICMJE Dr. Falk Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Axel Dignass, Prof. Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
PRS Account Dr. Falk Pharma GmbH
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP