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Crohn's DiseasePhase 3NCT00946946

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

A Phase 3 study testing Azathioprine and Mesalazine in people with Crohn's Disease, run by Dr. Falk Pharma GmbH at 2 sites in 2 countries.

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 aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic recurrence. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn's Disease
What is being tested?
Azathioprine and Mesalazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
2 sitesin 2 countries
Study dates
Feb 2002to Jul 2009
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent,
  • Man or woman between 18 and 70 years of age,
  • Diagnosis of Crohn's disease confirmed by endoscopic and histological, or endoscopic and radiological criteria within one year or by histopathological criteria during resection,
  • Clinical remission defined as Crohn´s Disease Activity Index (CDAI) < 200, within the last two weeks. No clinical relapse due to Crohn's disease since resection,
  • Moderate (i2a) or severe endoscopic recurrence (i3-i4) within 6 to 24 months after curative resection of the terminal ileum and partial colectomy with ileocolonic resection for complications of ileal Crohn´s disease and with a construction of an ileocolonic anastomosis,
  • Within the neoterminal ileum at least more than 5 aphthous lesions with normal mucosa between the lesions, or skip areas of larger lesions,
  • Negative pregnancy test at screening visit in females of childbearing potential,
  • Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment and at least up to 3 months after the end of treatment.

Who cannot join

  • Lesions confined to the ileocolonic anastomosis (i.e., < 1 cm in length)
  • Short bowel syndrome,
  • Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study,
  • Serum creatinine levels exceeding 1.5 mg/dL or 130 umol/L,
  • Presence of an ileo-/colonic stoma,
  • Genotype: thiopurine methyltransferase (TPMT) -/-,
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  • Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years),
  • Treatment with cytostatics or immunosuppressants, methotrexate, cyclosporine, 6-MP, Azathioprine, 6-TG or anti-TFN-alpha therapy since resection; postoperative treatment with corticosteroids for more than 4 weeks or postoperative treatment with oral antibiotics (e.g., metronidazole, ciprofloxacin) for more than 4 weeks,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Screening visit except low dose acetylsalicylic acid and except paracetamol,
  • Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile,
  • Scheduled or intended active immunisation with living vaccines within the next 12 months,
  • Well-founded doubt about the patient's cooperation,
  • Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 15 months,
  • Non-use of appropriate contraceptives in males with procreative capacity and females of childbearing potential (e.g. condoms for males, intrauterine device [IUD], hormonal contraception for females, or a means of contraception for a particular patient considered adequate by the responsible investigator) during treatment and within 3 months after the end of treatment,
  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial,
  • Present stricture plasty (no exclusion if the present stricture plasty was macroscopically without any relevant finding of inflammation seen during index surgery.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie

    Vienna, 1090

Other trials in Austria

Germany1 site

  • Robert-Bosch Krankenhaus, Innere Medizin I

    Stuttgart, Postfach 501120

Other trials in Germany

About this study

Official title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence

This study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic recurrence.

Conditions
Crohn's Disease
Being tested
Azathioprine, Mesalazine, Azathioprine placebo, Mesalazine placebo
Keywords
Randomized, Crohn's Disease, Prevention, Azathioprine, mesalazine, mesalamine, TPMT
Medical subject headings
Crohn Disease

What participants receive

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

  • AzathioprineDrug

    Also called Azafalk 50mg tablets

    2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

  • MesalazineDrug

    Also called Salofalk 500mg tablets

    4g Mesalazine tablets/day AND azathioprine placebo tablets

  • Azathioprine placeboDrug

    4g Mesalazine tablets/day AND azathioprine placebo tablets

  • Mesalazine placeboDrug

    2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

Study groups in NCT00946946
Study groupRoleWhat they receive
AzathioprineExperimental2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
Receives: Drug: Azathioprine; Drug: Mesalazine placebo
MesalazineActive comparator4g mesalazine tablets/day AND azathioprine placebo tablets
Receives: Drug: Mesalazine; Drug: Azathioprine placebo

What is being measured

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

  1. The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.

    Measured: 12 months

Secondary outcomes (3)

  1. endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score.

    Measured: 12 months

  2. change in CDAI score

    Measured: 12 months

  3. adverse events

    Measured: 12 months

Timeline

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

  1. First posted27 Jul 2009 (estimated)
  2. Study startFeb 2002
  3. Primary completionMay 2007
  4. Study completionJul 2009

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
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00946946
Sponsor's protocol ID
AZT-2/CDP
Status last verified
Jun 2012
First submitted
24 Jul 2009
Last updated
26 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Reinisch W, Angelberger S, Petritsch W, Shonova O, Lukas M, Bar-Meir S, Teml A, Schaeffeler E, Schwab M, Dilger K, Greinwald R, Mueller R, Stange EF, Herrlinger KR; International AZT-2 Study Group. Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial. Gut. 2010 Jun;59(6):752-9. doi: 10.1136/gut.2009.194159.

    PubMed 20551460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azathioprine and Mesalazine in people with Crohn's Disease, run by Dr. Falk Pharma GmbH at 2 sites in 2 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 16 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 2 sites in Austria, 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?

The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (time frame: 12 months). 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 NCT00946946, 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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