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

NCT00747110 | Completed Phase 3 DMC

• 2 other identifiers: BUC-57/UCA2006-005377-22
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colitis, Ulcerative

Keywords

5-ASA; mesalamine; mesalazine; budesonide; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF)

  week 8 (LOCF)

Secondary Outcomes (4)

• Time to first resolution of clinical symptoms

  within 8 weeks

• CAI in the course of the study

  week 0, 2, 4, 6, 8

• Disease Activity Index (DAI)in the course of the study

  week 0 and 8 (LOCF)

• Endoscopical Index (EI)in the course of the study

  week 0 and 8 (LOCF)

Study Arms (2)

A

EXPERIMENTAL

9mg budesonide OD

Drug: budesonide

B

ACTIVE COMPARATOR

3g mesalazine OD

Drug: mesalazine

Interventions

budesonide DRUG

3x 3mg budesonide capsules once daily

Also known as: Budenofalk 3mg capsules

A

mesalazine DRUG

3x 1000mg mesalazine onc daily

Also known as: Salofalk 1000mg granules

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent,
• Men or women aged 18 to 75 years,
• Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
• 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),
• Clinical Activity Index (CAI) \>= 6 and Endoscopical Index (EI) \>= 4,
• 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.

You may not qualify if:

• Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
• Toxic megacolon,
• Baseline stool positive for germs causing bowel disease,
• Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract,
• Active peptic ulcer disease,
• Haemorrhagic diathesis,
• Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured,
• Severe co-morbidity substantially reducing life expectancy,
• Active colorectal cancer or a history of colorectal cancer,
• 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,
• Immunosuppressants within 3 months and/or corticosteroids (oral, intravenous \[IV\] or topical rectal) within 4 weeks prior to baseline,
• Current relapse occurred under maintenance treatment with \> 2.4 g mesalazine per day,
• Abnormal renal function (Serum Cystatin C \> upper limit of normal \[ULN\]),
• Abnormal hepatic function (ALT, AST or AP \>= 2 x ULN) or liver cirrhosis,
• 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,

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead

Study Sites (1)

Klinikum St. Marien

Amberg, 92224, Germany

Location

Related Publications (1)

• Gross V, Bunganic I, Belousova EA, Mikhailova TL, Kupcinskas L, Kiudelis G, Tulassay Z, Gabalec L, Dorofeyev AE, Derova J, Dilger K, Greinwald R, Mueller R; International BUC-57 Study Group. 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2011 Apr;5(2):129-38. doi: 10.1016/j.crohns.2010.11.006. Epub 2010 Dec 14.

  PMID: 21453882 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Budesonide; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Ralph Mueller, Dr

  Dr. Falk Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2010
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

DE (1)