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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00329537 |
The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.
Condition | Intervention | Phase |
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Crohn Disease |
Drug: Leukine (Sargramostim, BAY86-5326) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study) |
Enrollment: | 66 |
Study Start Date: | June 2006 |
Study Completion Date: | May 2007 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Leukine (Sargramostim, BAY86-5326)
Self-subcutaneous injection
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Arm 2: Placebo Comparator |
Drug: Placebo
Self-subcutaneous injection
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Yakuhin Ltd. ( Head Clinical Pharmacology ) |
Study ID Numbers: | 91510, 309240, A36774 |
Study First Received: | May 23, 2006 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00329537 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Crohn's disease sargramostim CDAI Moderately to severely active Crohn's disease |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |