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Colitis, UlcerativePhase 3NCT00746447

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

A Phase 3 study testing mesalamine granules in people with Colitis, Ulcerative and Recurrence, 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

This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colitis, Ulcerative, Recurrence
What is being tested?
mesalamine granules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
1 siteGermany
Study dates
May 2005to Mar 2008
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,
  • Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology,
  • Patient being in remission, defined (according to Rachmilewitz) as:
  • Clinical Activity Index (CAI) <= 4, and Endoscopic Index (EI) < 4,
  • Extent of inflammation during last acute episode was >15 cm beyond the anal margin,
  • Last acute episode ended within 3 months prior to study entry.

Who cannot join

  • Crohn's disease,
  • Prior bowel resection leading to diarrhoea,
  • Toxic megacolon,
  • Gastric or duodenal ulcer,
  • Haemorrhagic diathesis,
  • Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
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  • Active colorectal cancer or a history of colorectal cancer,
  • Serious other secondary illnesses of an acute or chronic nature,
  • Asthma,
  • Severe impairment of renal (e.g., serum creatinine > 1.5 mg/dl) and/or liver functions (e.g., serum transaminase [ALT and/or AST] or alkaline phosphatase >=2x upper limit of normal [ULN]),
  • Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to baseline,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e. > 6 weeks), other than acetylsalicylic acid (<= 350 mg/day), or paracetamol,
  • Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
  • Well-founded doubt about the patient's cooperation,
  • Existing or intended pregnancy, breast-feeding,
  • Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
  • 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

  • Evangelisches Krankenhaus Kalk, Medical Dept.

    Cologne, 51103

Other trials in Germany

About this study

Official title: Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis

This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis

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

What participants receive

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

  • mesalamine granulesDrug

    Also called Salofalk granules, Mesalazine

    3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;

  • mesalamine granulesDrug

    Also called Salofalk granules, Mesalazine

    1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;

  • mesalamine granulesDrug

    Also called Salofalk granules, Mesalazine

    0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening

Study groups in NCT00746447
Study groupRoleWhat they receive
3.0g ODExperimentalNot described
Receives: Drug: mesalamine granules
1.5g ODExperimentalNot described
Receives: Drug: mesalamine granules
0.5g TIDActive comparatorNot described
Receives: Drug: mesalamine granules

What is being measured

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

  1. Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline.

    Measured: week 52 or premature withdrawal

Secondary outcomes (2)

  1. Time to relapse

    Measured: within 52 weeks

  2. Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination.

    Measured: week 52 or premature withdrawal

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 startMay 2005
  3. Primary completionApr 2007
  4. Study completionMar 2008

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00746447
Sponsor's protocol ID
SAG-27/UCR
Other IDs
EudraCT No.: 2004-001218-15
Status last verified
Jun 2012
First submitted
3 Sep 2008
Last updated
26 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Batovsky M, Lozynsky YS, Zakharash Y, Racz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group. Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi: 10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8.

    PubMed 21138455

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mesalamine granules in people with Colitis, Ulcerative and Recurrence, 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 7 inclusion and 17 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?

Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline. (time frame: week 52 or premature withdrawal). 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 NCT00746447, 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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