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Colitis, UlcerativePhase 3NCT00747110

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

A Phase 3 study testing budesonide and mesalazine in people with Colitis, Ulcerative, run by Dr. Falk Pharma GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
budesonide and mesalazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
1 siteGermany
Study dates
Oct 2007to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 18Show fewer
  • 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,
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum St. Marien

    Amberg, 92224

Other trials in Germany

About this study

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

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.

Being tested
budesonide, mesalazine
Keywords
5-ASA, mesalamine, mesalazine, budesonide, ulcerative colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • budesonideDrug

    Also called Budenofalk 3mg capsules

    3x 3mg budesonide capsules once daily

  • mesalazineDrug

    Also called Salofalk 1000mg granules

    3x 1000mg mesalazine onc daily

Study groups in NCT00747110
Study groupRoleWhat they receive
AExperimental9mg budesonide OD
Receives: Drug: budesonide
BActive comparator3g mesalazine OD
Receives: Drug: mesalazine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: week 8 (LOCF)

Secondary outcomes (4)

  1. Time to first resolution of clinical symptoms

    Measured: within 8 weeks

  2. CAI in the course of the study

    Measured: week 0, 2, 4, 6, 8

  3. Disease Activity Index (DAI)in the course of the study

    Measured: week 0 and 8 (LOCF)

  4. Endoscopical Index (EI)in the course of the study

    Measured: week 0 and 8 (LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionAug 2008
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00747110
Sponsor's protocol ID
BUC-57/UCA
Other IDs
2006-005377-22
Status last verified
Jun 2012
First submitted
3 Sep 2008
Last updated
26 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21453882

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing budesonide and mesalazine in people with Colitis, Ulcerative, run by Dr. Falk Pharma GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00747110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.

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