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Trial Information
Summary: Active Crohn's Disease: International, Multicenter, Double-Blind, Placebo-controlled study for moderate to severe Crohn's Disease.
Study Description
Screening period of 7-10 days
- Physical examination, laboratory tests & Chest X-ray
- Daily diary
- Questionnaire
Treatment period of 10 weeks
- Monthly infusions
- 5 Study visits (3 infusions & 3 office visits)
Follow-up phase
- 12, 20 & 32 week visits
- Potential candidate for long term study
Inclusion
- 18 years of age or older
- History of Crohn's Disease for at least 6 months confirmed
radiological or endoscopic confirmation
- Stable low dose prednisolone (or equivalent)
Exclusion Criteria
- Oral prednisolone (or equivalent) exceeding 25 mg/day
- Use of anti-TNF therapy in the last 90 days
- Use of herbal preparations during therapy
- Subject with colostomy, ileostomy or short bowel
syndrome
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Contact:
Gail Danhour, RN
Rocky Mountain Clinical Research, Inc.
29 Rogers Court
Golden, CO 80401
Telephone: 303-279-1550
Fax: 303-278-2602
Email:
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Trial listings updated: June 1, 2008 at 5:43:22 AM
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