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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01086553
First received: March 12, 2010
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Crohn´s Disease
Drug: budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
9mg budesonide OD
Drug: budesonide
9mg budesonide OD
Active Comparator: B
3mg budesonide TID
Drug: budesonide
3mg budesonide TID

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086553

Locations
Germany
Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
Frankfurt, Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Axel Dignass, Prof. Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01086553     History of Changes
Other Study ID Numbers: BUG-2/CDA, 2008-006957-42
Study First Received: March 12, 2010
Last Updated: December 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
Crohn´s disease
budesonide
induction of remission

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014