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NCT01016808 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
A Phase 3 study, sponsored by QRxPharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT01016808 is a Phase 3 study that has completed, run by QRxPharma. The registered enrollment target is 522 participants.
The verdict
NCT01016808, a Phase 3 study, has completed, sponsored by QRxPharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.
Interventions
- DRUG Morphine sulfate
- DRUG Oxycodone HCl
- DRUG Q8003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01016808
The ClinicalTrials.gov registry entry for NCT01016808 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QRxPharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Morphine sulfate is the first listed.
NCT01016808 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01016808 about?
NCT01016808 is a clinical study titled "Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients". This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.
What is the current status of trial NCT01016808?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2009-12. Estimated completion is 2010-03.
What interventions are being tested in trial NCT01016808?
The interventions under investigation include: Morphine sulfate (DRUG), Oxycodone HCl (DRUG), Q8003 (DRUG).
Who is sponsoring clinical trial NCT01016808?
This trial is sponsored by QRxPharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
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