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

Crohn´s Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086553
• Other study ID #: BUG-2/CDA
• Secondary ID: 2008-006957-42
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2010
• Last updated: October 29, 2014
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Intervention

Drug:
• budesonide
9mg budesonide OD
• budesonide
3mg budesonide TID

Locations

Country	Name	City	State
Germany	Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsová E, Altorjay I, Tuculanu D, Bunganic I, Pokrotnieks J, Kupcinskas L, Dilger K, Greinwald R, Mueller R; International Budenofalk Study Group. Once versus three times daily dosing of oral budesonide — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)		8 weeks	No
Secondary	Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points		8 weeks	No
Secondary	Adverse events		8 weeks	Yes