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Sponsors and Collaborators: |
Sucampo Pharmaceuticals, Inc. Takeda Pharmaceutical Company Limited |
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Information provided by: | Sucampo Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00620061 |
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in patients with OBD.
Condition | Intervention | Phase |
---|---|---|
Opioid-Induced Bowel Dysfunction |
Drug: Lubiprostone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Labeled Study of the Long-Term Safety and Efficacy of Lubiprostone in Patients With Opioid-Induced Bowel Dysfunction |
Estimated Enrollment: | 440 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Lubiprostone
24 mcg capsules twice daily (BID) for 9 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: OPAL Study | OPALstudy@sucampo.com |
Responsible Party: | Sucampo Pharmaceuticals, Inc. ( Clinical Trial Manager ) |
Study ID Numbers: | OBD06S1 |
Study First Received: | February 11, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00620061 |
Health Authority: | United States: Food and Drug Administration |