Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 3/1/2019 |
| Start Date: | February 17, 2009 |
| End Date: | April 18, 2011 |
An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
When post-operative parenteral analgesia is discontinued, oral dosing with study medication
may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
(pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
promotes opioids and no longer markets Opana® ER.
may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
(pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
promotes opioids and no longer markets Opana® ER.
Inclusion Criteria:
- Male or female > 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours
following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Exclusion Criteria:
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of < 4 weeks
- Positive pregnancy test at screening
We found this trial at
11
sites
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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