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

Dr. Falk Pharma

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Drug: budesonide

Drug: mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00300118

BUC-52/CDA

2004-001213-34

Details and patient eligibility

About

The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Full description

Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.

So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.

Enrollment

311 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (main):

Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria [endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes]
Localisation of CD either in terminal ileum, ascending colon or ileocolitis
Active phase of disease (200 < CDAI < 400)

Exclusion Criteria (main):

Known Crohn's lesion in the upper GI-tract (up to and including the jejunum) with present symptoms
CD in the rectum currently present
Short bowel syndrome
Septic complications
Baseline stool positive for germs causing bowel disease
Abscess, perforation or active fistulas
Ileostomy or colostomy
Resection of more than 50 cm of the ileum
Bowel surgery within the last 3 months
Immediate surgery required
Clinical signs of stricturing disease
Subileus within the last 6 months
Suspicion of ileus, subileus or corresponding symptomatology
Contra-indications, special warnings and precautions mentioned in SmPC
Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study
Treatment with ketoconazole, ciprofloxacin or other CYP3A inhibitors within the last month before baseline visit
Treatment with anti-TNF-a therapy within 6 months before baseline visit
Conventional steroids (iv, po, rectal) within 2 weeks before the study
> 6 mg/d budesonide po or > 3 g/d mesalazine po within 2 weeks before the study
Patients known to be steroid-refractory or steroid-dependent from former CD episodes
Treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks