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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

NCT00976690

Crohn Disease

COMPLETED PHASE3

Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.

NCT02247258

Crohn Disease Recurrence Azathioprine +1 more

TERMINATED PHASE2

Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

NCT01514240

Crohn's Disease

COMPLETED PHASE3

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

NCT00300118

Crohn's Disease

COMPLETED PHASE3

Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

NCT00573469

Crohn's Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Azathioprine

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

Group Type EXPERIMENTAL

Azathioprine

Intervention Type DRUG

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

Mesalazine placebo

Intervention Type DRUG

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

Mesalazine

4g mesalazine tablets/day AND azathioprine placebo tablets

Group Type ACTIVE_COMPARATOR

Mesalazine

Intervention Type DRUG

4g Mesalazine tablets/day AND azathioprine placebo tablets

Azathioprine placebo

Intervention Type DRUG

4g Mesalazine tablets/day AND azathioprine placebo tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azathioprine

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

Intervention Type DRUG

Mesalazine

4g Mesalazine tablets/day AND azathioprine placebo tablets

Intervention Type DRUG

Azathioprine placebo

4g Mesalazine tablets/day AND azathioprine placebo tablets

Intervention Type DRUG

Mesalazine placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Azafalk 50mg tablets Salofalk 500mg tablets

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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) -/-,
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No