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NCT00801398 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT00801398: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00801398 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00801398, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Oxymorphone IR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2009-02-17 |
| Est. Completion | 2011-04-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00801398
The ClinicalTrials.gov registry entry for NCT00801398 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxymorphone IR is the first listed.
NCT00801398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00801398 about?
NCT00801398 is a clinical study titled "Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative 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 Pharma...
What is the current status of trial NCT00801398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2009-02-17. Estimated completion is 2011-04-18.
What interventions are being tested in trial NCT00801398?
The interventions under investigation include: Oxymorphone IR (DRUG).
Who is sponsoring clinical trial NCT00801398?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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