Status:
COMPLETED
Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis
Lead Sponsor:
AM-Pharma
Collaborating Sponsors:
CRM Biometrics GmbH
Sintesi Research Srl
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Ulcerative colitis is characterized by abnormal activation of, and damage to, the colon epithelium, which is considered to be a central pathogenic mechanism. Activation of colon epithelium cells in UC...
Detailed Description
Inflammatory Bowel Disease (IBD) is a general term for a group of non-specific, chronic inflammatory disorders of the digestive tract, of unknown etiology. IBD may be divided in two major categories: ...
Eligibility Criteria
Inclusion
- Age, \>18 years, AND
- Capable of understanding the purpose and risks of the study and have provided a signed and dated written IC, AND
- Prior to the study baseline, been treated with oral steroid medication, of which \> 2 weeks on oral prednisone equivalent of at least 40mg/day, and still have:
- active ulcerative colon disease documented by a MAYO score of 6-11, and
- active ulcerative colon disease documented by a MTWSI score of 7-15
- OR
- Prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Subjects have been treated for a minimum of 12 weeks, and still have:
- chronic active ulcerative colon disease documented by a MAYO score of 6-11, and
- chronic active ulcerative colon disease documented by a MTWSI score of 7-15
- OR
- Prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as:
- chronic active ulcerative colon disease documented by a MAYO score of 6-11, and
- chronic active ulcerative colon disease documented by a MTWSI score of 7-15.
Exclusion
- UC, requiring immediate surgical, endoscopic, or radiological intervention; including massive haemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or peri-anal abscesses) or toxic colon,
- history of large bowel surgery,
- history of serious infections,
- positive stool cultures, including Clostridium difficile,
- significant organ dysfunction,
- pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives,
- treatment with:
- an altered dose of any 5-ASA preparation within 4 weeks of screening,
- an altered dose of azathioprine or mercaptopurine within 4 weeks of screening (stable dosage of immunosuppressives is allowed), or start of azathioprine in the last 3 months prior to baseline,
- probiotics, antibiotics within 1 month, methotrexate or cyclosporine within 2 months prior to screening,
- any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNFα therapy) within 2 months of screening.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00727324
Start Date
May 1 2006
End Date
December 1 2006
Last Update
April 2 2012
Active Locations (11)
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1
Internal Clinic, Vitkovice Hospital Ostrava
Ostrava, Vitkovice, Czechia, 703 84
2
Teaching Hospital Olomouc, Dep. Internal Clinic
Olomouc, Czechia, 775 20
3
Center of Gastroenterology at General Teaching Hospital
Prague, Czechia, 120 00
4
Institute of Clinical and Preventive Medicine (IKEM), Clinic of Hepatogastroenterology
Prague, Czechia, 40 21