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Ulcerative ColitisPhase 3NCT00737789

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.

A Phase 3 study testing Mesalazine slow-release granules and Mesalazine liquid enema in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 66 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Mesalazine slow-release granules and Mesalazine liquid enema
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
66 sitesin 4 countries
Study dates
Nov 2008to Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be included if they comply with the following inclusion criteria determined at baseline, prior to first drug administration:
  • Aged over 18 years.
  • Newly diagnosed or relapsing mild to moderate ulcerative colitis with disease extension beyond rectum (of at least 12-18 cm from the anorectal junction). All patients must have had at least one total colonoscopy in their disease history (within the previous 5 years).
  • Disease activity will be assessed on the 15 days before inclusion and according to ulcerative colitis disease activity index (UC-DAI) score. The UC-DAI score will be from 3 to 8 (mild: 3-5 or moderate: 6-8).
  • Men or non pregnant women.
  • Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
  • Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months at stable dose and continued at the same dose throughout the study) is permitted.
  • Informed consent given.

Who cannot join

  • The patients will not be included in the study if one of the following exclusion criteria is fulfilled at baseline, prior to first drug administration:
  • Proctitis (less than 12-18 cm from the anorectal junction).
  • Previous colonic surgery.
  • Previously failed to respond to steroids within the previous year.
  • Non-response to rectal 5-Amino Salicylic Acid (5-ASA) therapy or to oral 5-ASA therapy at a dose > 3g/day for induction of remission within the previous year.
  • Current relapse lasting more than 6 weeks (for patient recently diagnosed the period of 6 weeks runs from the endoscopic diagnosis)(from what patient says).
Show all 24Show fewer
  • Severe/fulminant ulcerative colitis.
  • Evidence of other forms of inflammatory bowel disease or infectious disease.
  • Allergy to aspirin or salicylate derivatives.
  • The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
  • Loperamide and other antidiarrheal agents, mucilages, antibiotics: 1 week wash-out.
  • Oral steroids: 4 weeks wash-out.
  • Rectal steroids: 2 weeks wash-out
  • Repeated treatment (> 3days of use) of non steroidal anti-inflammatory drugs (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤ 325 mg/day used for cardioprotection is allowed).
  • Sulfasalazine > 4g/day or mesalazine or 4-ASA at a higher dose than what is permitted in the local formulary or standard care for maintenance treatment: 4 weeks wash-out
  • Immunomodulating/suppressing drugs: 3 month for wash out (except for patients maintained on azathioprine or 6-mercaptopurine -see above).
  • Known significant hepatic or renal function abnormalities.
  • Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine plasma value > 1.5 x Upper Limit of Normal (ULN) or white blood cells < 3500/mm˄3 or > 15000/mm˄3 or Platelets < 100000/mm˄3 or > 800000/mm˄3 or aspartate aminotransferase/alanine Aminotransferase (ASAT/ALAT) > 3 x ULN or Gamma glutamyl transpeptidase (GGT)/Alkaline Phosphatase's > 3 x ULN (Primary Sclerosing Cholangitis is not an exclusion criteria).
  • History or physical examination findings indicative of active alcohol or drug abuse,
  • Pregnancy or breast-feeding,
  • History of disease, including mental/emotional disorder, that might interfere with their participation in the study,
  • Participation in another clinical study in the last 3 months.
  • Inability to comply with the protocol requirements.
  • Inability to fill in the diary cards.

Trial locations and contacts

66 sites in 4 countries.

66 sites in 4 countries

France50 sites

  • Clinique Esquirol-St Hilaire

    Agen

  • Investigational site

    Albi

  • Investigational site

    Amiens

  • Centre Hospitalier Avignon

    Avignon

  • Centre Hospitalier Bethune

    Béthune

  • Investigational site

    Bourgoin

  • Investigational site

    Brest

  • Clinique Jean-Villar

    Bruges

  • Clinique Saint Martin - 18 rue Rocquemonts

    Caen

  • Clinique Saint Martin

    Caen

  • Investigational site

    Caluire-et-Cuire

  • Investigational site

    Carcassonne

  • Clinique du Parc

    Castelnau-le-Lez

  • Investigational site

    Chambray-lès-Tours

  • Centre Médical République

    Clermont-Ferrand

  • Investigational site

    Clichy

  • Clinique des Cèdres

    Cornebarrieu

  • Centre Hospitalier Intercommunal

    Créteil

  • Investigational site

    Dunkirk

  • Centre Hospitalier Universitaire Albert MICHALON

    Grenoble

  • Investigational site

    Grenoble

  • Investigational site

    Hazebroucq

  • Investigational site

    Irigny

  • Investigational site

    Istres

  • Centre Hospitalier Lagny

    Lagny

  • Investigational site

    Le Mans

  • Investigational site - 23 bis, place Sébastol

    Lille

  • Investigational site - 60 rue Jean Bart

    Lille

  • Clinique de la Sauvegarde

    Lyon

  • Investigational site - 186 avenue de la Rose

    Marseille

  • Investigational site - 23 Cours Gouffé

    Marseille

  • Investigational site

    Miramas

  • CH Le raincy-Montfermeil

    Montfermeil

  • Investigational site

    Nancy

  • Hôpital L'Archet 2

    Nice

  • Investigational site - 127 boulevard St Germain

    Paris

  • Investigational site - 72 rue Archeveau

    Paris

  • Investigational site - 91 rue Caulaincourt

    Paris

  • Investigational site

    Perpignan

  • Clinique Saint Martin

    Pessac

  • Hôpital de Lyon Sud

    Pierre-Bénite

  • Investigational site

    Reims

  • Centre Hospitalier Privé

    Saint-Grégoire

  • Investigational site - 140 avenue Lwoff

    Saint-Priest

  • Investigational site

    Saint-Quentin

  • Investigational site

    Strasbourg

  • Clinique Saint Jean Languedoc - 20 route de Revel

    Toulouse

  • Clinique Saint Jean-Languedoc

    Toulouse

  • Groupe Hospitalier les Portes du Sud

    Vénissieux

  • Centre FUTURA MEDICA

    Verquigneul

Other trials in France

Netherlands7 sites

  • Kennemer Gasthuis, loc. EG

    Haarlem

  • Streekziekenhuis Midden Twente

    Hengelo

  • IJsselmeer Ziekenhuis Loc. Lelystad, Poli MDL

    Lelystad

  • Mumc / Azm

    Maastricht

  • Haga Ziekenhuis, loc.Rode Kruis

    The Hague

  • TweeSteden Ziekenhuis

    Tilburg

  • Isala Klinieken, loc. Sophia

    Zwolle

Other trials in Netherlands

Belgium6 sites

  • O.L.Vrouwziekenhuis Campus Aalst

    Aalst

  • C.H.U. Saint-Pierre

    Brussels

  • Saint Luc University Hospital

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

  • U.Z. Antwerpen

    Edegem

  • University Hospital Gasthuisberg

    Leuven

Other trials in Belgium

United Kingdom3 sites

  • Bristol Royal Infirmary

    Bristol

  • Addenbrooke's Hospital

    Cambridge

  • Royal Victoria Infirmary

    Newcastle

Other trials in United Kingdom

About this study

Official title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.

The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

Read the detailed description

A key element in therapeutic response in UC is treatment compliance. In daily practice, compliance of UC patients with 5-Amino Salicylic Acid (5-ASA) treatment appears mediocre, particularly in maintenance therapy. Poor or non-existent compliance affects not only treatment response but also disease progression.

An inverse relationship has been found between the number of daily doses prescribed and treatment compliance. Thus, reduction to a single daily dose of mesalazine is a major factor likely to significantly increase treatment compliance.

Reducing the dosing rate to a single daily dose for 8 weeks constitutes a simple method of improving treatment compliance but it is necessary to demonstrate at least equivalent efficacy compared to the twice daily dosing which is the reference regimen. This study was designed to show that mesalazine 4g once daily is at least as effective as mesalazine 4g in two divided doses per day in patients with mild to moderate ulcerative colitis after 8 weeks of treatment with a better compliance. To improve remission, both groups received an enema during the first 4 weeks, as usually done in current practice.

Being tested
Mesalazine slow-release granules, Mesalazine liquid enema
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Mesalazine slow-release granulesDrug

    Also called Pentasa

    Mesalazine 2g Sachet prolonged release granules, administered orally.

  • Mesalazine liquid enemaDrug

    1g mesalazine liquid enema, administered topically once a day in the evening.

Study groups in NCT00737789
Study groupRoleWhat they receive
Mesalazine once/dayExperimentalParticipants received 4g oral Mesalazine once a day (2 sachets of prolonged release granules) for 8 weeks during the induction period. In addition, participants received a liquid enema of 1g Mesalazine once a day at bedtime for the first 4 weeks. Participants who were in remission at Week 8 received oral mesalazine 2g once daily (1 sachet/day) for an additional 4 weeks (maintenance period).
Receives: Drug: Mesalazine slow-release granules; Drug: Mesalazine liquid enema
Mesalazine twice/dayActive comparatorParticipants received oral mesalazine 4 g per day in two divided doses (1 sachet prolonged release granules twice a day) for 8 weeks during the induction period. In addition, participants received a liquid enema of 1g Mesalazine once a day at bedtime for the first 4 weeks. Participants who were in remission at Week 8 received oral Mesalazine 2g (one sachet) once a day for an additional 4 weeks (maintenance period).
Receives: Drug: Mesalazine slow-release granules; Drug: Mesalazine liquid enema

What is being measured

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

  1. Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1

    Measured: 12 weeks

Secondary outcomes (9)

  1. Compliance

    Measured: Week 8

  2. Clinical remission

    Measured: At week 4, week 8 and week 12

  3. Treatment failure is defined as need of other treatment (ie steroids, immunosuppressive or immunomodulating drugs) than those allowed by the protocol, as judged by investigator. Treatment failure will be counted as non-remission.

    Measured: At week 4 and week 8

  4. Clinical variables (stool frequency and bloody stools)

    Measured: At week 4, 8 and 12 separately

  5. Time to remission according to patient's diary (normal stool frequency and cessation of bleeding)

    Measured: At week 4 and week 8

  6. Time to cessation of bleeding

    Measured: At week 4, week 8 and week 12

  7. Improvement - based on UC-DAI score

    Measured: At week 4 and 8

  8. Endoscopic assessment

    Measured: At week 0 and week 8

  9. Safety

    Measured: At week 0, week 4, week 8 and week 12

Timeline

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

  1. First posted20 Aug 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJun 2010
  4. Study completionJun 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
Single blind
Who is masked
Investigator
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737789
Sponsor's protocol ID
Pentasa FE999907 CS06
Other IDs
EudractCT No 2008-000045-59
Status last verified
Mar 2015
First submitted
19 Aug 2008
Last updated
4 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Flourie B, Hagege H, Tucat G, Maetz D, Hebuterne X, Kuyvenhoven JP, Tan TG, Pierik MJ, Masclee AA, Dewit O, Probert CS, Aoucheta D; MOTUS study investigators. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013 Apr;37(8):767-75. doi: 10.1111/apt.12266. Epub 2013 Mar 4.

    PubMed 23451806

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesalazine slow-release granules and Mesalazine liquid enema in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 66 sites in 4 countries.

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 8 inclusion and 24 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in France, Netherlands, Belgium, United Kingdom. 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?

Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (time frame: 12 weeks). 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 NCT00737789, 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 4 Mar 2015.

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