Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
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|ClinicalTrials.gov Identifier: NCT00226395|
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : February 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Oxymorphone immediate release||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||September 2004|
|Study Completion Date :||August 2005|
- Time to discontinuation due to all causes
- The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- - 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- - 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
- - Time (in hours) to First Perceptible Pain Relief
- - Time (in hours) to Meaningful Pain Relief
- - Hourly Pain Relief Scores
- - Hourly Pain Intensity Difference Scores
- The following are the secondary endpoints during the multiple dosing phase:
- - Mean average pain intensity scores collected during the dosing intervals.
- - Mean current pain intensity (VAS) collected during the dosing intervals.
- - Patient's global evaluation of study medication at the end of study.
- - Physician's global evaluation of study medication at the end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226395