Budesonide and Mesalazine in Patients with Active Sinistrial Colitis

Phase 2

• Conditions: K51.0; Ulcerative (chronic) pancolitis

• Registration Number: DRKS00000308
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2000-08-28
• Study Start: 2010-04-06
• Results First Posted: 2010-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

Active left sided colitis ulcerosa
Diagnosis confirmed by endoscopy or histology
History of at least one acute attack
Maximal extent of disease tot he sinistrial flexure
Clinical activity score => 4
Endoscopy score => 2
Negative stool culture
Aged 18 years or older
Written consent to participation in the study

Exclusion Criteria

Infectious origin of colitis
Preceding treatments:
-Glucocorticoids (oral, parenteral, or rectal) within the two weeks preceding inclusion, exempt contraceptivs, estrogenic hormons, eye-drops and ointmets/creams containing prednisolone derivativs,
-Immune suppressive drugs (azathioprine, 6-mercaptopurine, Methotrexate, Cyclosporine) within the preceding 6 months,
-5-amonosalicyclic acid (5-ASA), sulphasalazine, or olsalazine in variable dosage within the preceding 2 weeks
-NSAIDs for more than 3 consecutive days
-Antibiotics during the preceding 2 weeks other that following a defined infection for less than 10 days
-Anticoagulants
-Oral antidiabetic medicaton or sulfonic carbamide type,
-Spironolactone, furosemide
-Probenicide, sulfinpyrazone
-Rifampicin
Active immunization against virus or bacteria within the preceding 3 months
Pregnancy, planned pregnancy, lactation period,
Clinical significant hepatic, nephritic, or cardiovascular concomitant disease that could influence resorption, metabolism or excretion of test medication
Known intolerance to salycilate or budesonide,
Participation in other therapeutical trials within the preceding month,
Previous randomisation within this study,
Alcohol or drug dependency,
Expected lack of compliance with the study protocol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the tolerability of rectal injections of Budesonide and Mesalazine, measured in terms of number of patients affected by adverse events and number of withdrawls from study treatmant

Secondary Outcome Measures

Name	Time	Method
Rates of clinical remission after 4 weeks and endoscopic remission after 8 weeks of treatmant.<br>Clinical remission was defined in terms of a clinical activity index (remission: index < 4)<br>Endoscopic remission was defined in terms of an endoscopic score (remission: endoscopic score < 2)