Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00747110
First received: September 3, 2008
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.


Condition Intervention Phase
Colitis, Ulcerative
Drug: budesonide
Drug: mesalazine
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, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) [ Time Frame: week 8 (LOCF) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first resolution of clinical symptoms [ Time Frame: within 8 weeks ] [ Designated as safety issue: No ]
  • CAI in the course of the study [ Time Frame: week 0, 2, 4, 6, 8 ] [ Designated as safety issue: No ]
  • Disease Activity Index (DAI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ] [ Designated as safety issue: No ]
  • Endoscopical Index (EI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
9mg budesonide OD
Drug: budesonide
3x 3mg budesonide capsules once daily
Other Name: Budenofalk 3mg capsules
Active Comparator: B
3g mesalazine OD
Drug: mesalazine
3x 1000mg mesalazine onc daily
Other Name: Salofalk 1000mg granules

  Eligibility

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

Inclusion Criteria:

  1. Signed informed consent,
  2. Men or women aged 18 to 75 years,
  3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
  4. Established disease (presence of blood or mucus in the stools) or new diagnosis (bloody stools occurring at least during 14 days prior to baseline visit),
  5. Clinical Activity Index (CAI) >= 6 and Endoscopical Index (EI) >= 4,
  6. Women of child-bearing potential, if heterosexually active, have to apply a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptive method, some intrauterine devices (IUDs), sexual abstinence, or vasectomised partner. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

  1. Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
  2. Toxic megacolon,
  3. Baseline stool positive for germs causing bowel disease,
  4. Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract,
  5. Active peptic ulcer disease,
  6. Haemorrhagic diathesis,
  7. Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured,
  8. Severe co-morbidity substantially reducing life expectancy,
  9. Active colorectal cancer or a history of colorectal cancer,
  10. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible,
  11. Immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 4 weeks prior to baseline,
  12. Current relapse occurred under maintenance treatment with > 2.4 g mesalazine per day,
  13. Abnormal renal function (Serum Cystatin C > upper limit of normal [ULN]),
  14. Abnormal hepatic function (ALT, AST or AP >= 2 x ULN) or liver cirrhosis,
  15. Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drugs,
  16. Doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
  17. Existing or intended pregnancy or breast-feeding,
  18. 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747110

Locations
Germany
Klinikum St. Marien
Amberg, Germany, 92224
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Study Director: Ralph Mueller, Dr Dr. Falk Pharma GmbH
  More Information

Publications:
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00747110     History of Changes
Other Study ID Numbers: BUC-57/UCA, 2006-005377-22
Study First Received: September 3, 2008
Last Updated: June 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
5-ASA
mesalamine
mesalazine
budesonide
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Budesonide
Mesalamine
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014