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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 23, 2005 |
| Last Updated Date | May 15, 2009 |
| Start Date ICMJE | September 2004 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
Time to discontinuation due to all causes |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00226395 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |
| Brief Title ICMJE | Efficacy and Safety of Oxymorphone Immediate Release in Post-Surgical Acute Pain |
| Official Title ICMJE | Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery |
| Brief Summary | The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain. |
| Detailed Description | Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose. |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Acute Pain |
| Intervention ICMJE | Drug: Oxymorphone immediate release |
| Study Arms / Comparison Groups | |
| 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 |
| Enrollment ICMJE | 320 |
| Completion Date | August 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT00226395 |
| Responsible Party | |
| Study ID Numbers ICMJE | EN3203-009 |
| Study Sponsor ICMJE | Endo Pharmaceuticals |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Endo Pharmaceuticals |
| Verification Date | May 2009 |
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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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