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NCT01280331 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients
A Phase 3 study of Postoperative Pain, sponsored by QRxPharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
- 4
- Study locations
NCT01280331: Completed Phase 3 study of Postoperative Pain, sponsored by QRxPharma.
NCT01280331 is a Phase 3 study of Postoperative Pain that has completed, run by QRxPharma. The registered enrollment target is 375 participants, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (64% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01280331, a Phase 3 study of Postoperative Pain, has completed, sponsored by QRxPharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.
Conditions Studied
Interventions
- DRUG Q8003 (morphine sulfate and oxycodone hydrochloride)
- DRUG Morphine sulfate
- DRUG Oxycodone HCl
Study Locations (4)
Maryland
- Investigational site - Owings Mills
- Investigational site - Pasadena
California
- Investigational site - Anaheim
Texas
- Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT01280331 record still lists
NCT01280331 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (64% higher).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 3 interventions - of which Q8003 (morphine sulfate and oxycodone hydrochloride) is the first listed.
NCT01280331 reports a single indexed study location in Maryland, California, Texas.
Frequently Asked Questions
What is clinical trial NCT01280331 about?
NCT01280331 is a clinical study titled "Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients". This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surge...
What is the current status of trial NCT01280331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2011-01. Estimated completion is 2011-04.
What conditions does trial NCT01280331 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT01280331?
The interventions under investigation include: Q8003 (morphine sulfate and oxycodone hydrochloride) (DRUG), Morphine sulfate (DRUG), Oxycodone HCl (DRUG).
Who is sponsoring clinical trial NCT01280331?
This trial is sponsored by QRxPharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01280331 being conducted?
This trial has 4 study locations across California, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01280331's enrollment target sits among peer trials
375 13th of 120 higher than 108 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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