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| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | August 19, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00580294 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) | ||||
| Official Title ICMJE | A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone | ||||
| Brief Summary | he purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the swithcing from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: oxymorphone IV | ||||
| Study Arms / Comparison Groups | Experimental: Drug | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:Non-ambulatory patients
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00580294 | ||||
| Responsible Party | Marco Pappagallo, Mount Sinai School of Medicine | ||||
| Study ID Numbers ICMJE | GCO# 07-0464 | ||||
| Study Sponsor ICMJE | Mount Sinai School of Medicine | ||||
| Collaborators ICMJE | Endo Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | Mount Sinai School of Medicine | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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