EUCTR2004-004083-77-CZ
Active, not recruiting
Not Applicable
A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease
Disphar International B.V.0 sites436 target enrollmentDecember 2, 2004
ConditionsModerate active Crohn disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Moderate active Crohn disease
- Sponsor
- Disphar International B.V.
- Enrollment
- 436
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To participate in this trial, patients will have to meet all of the following criteria:
- •\-established diagnosis of Crohn disease in Moderate active status verified by clinical evaluation, laboratory tests and by X\-ray examination or/and colonoscopy and histology
- •\-Crohn disease of at least 3 months duration
- •\-acute exacerbation of moderate Crohn disease with a CDAI score between 220–400 points
- •\-patients between 18–75 years, both sexes
- •\-written informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients meeting any of the following criteria will be excluded from participation in this study:
- •\-positive stool culture for enteric pathogens including Salmonella, Shigella, Yersinia or Campylobacter
- •\-pregnant or lactating women
- •\-women of child bearing potential not taking adequate contraceptive precautions
- •\-maintenance treatment with higher daily doses (orally or rectally) than 4 g of Sulfasalazine or 2 g of Mesalazine EC 500 mg or any derivative up to one month before entering the study
- •\-chronic use of any anti\-inflammatory drugs, including NSAID´s (rectally or orally) within 7 days prior to inclusion; chronic use is defined as intake of medication every day for more than 7 consecutive days
- •\-chronic administration of any steroids is an exclusion criterion within 7 days before entering the study
- •\-chronic administration of any immunosuppressive agents is an exclusion criterion within 3 months before entering the study
- •\-any other disease or condition which may interfere with study assessments as judged by the investigator
- •\-alcohol or drug abuse
Outcomes
Primary Outcomes
Not specified
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Unknown
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