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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: Completed Phase 3 study, sponsored by QRxPharma.

NCT01016808 is a Phase 3 study that has completed, run by QRxPharma. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 522 participants
Start Date 2009-12
Est. Completion 2010-03
Phase Phase 3
QRxPharma

7 total trials

What the finished NCT01016808 record still lists

NCT01016808 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 3 interventions - of which Morphine sulfate is the first listed.

NCT01016808 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01016808's enrollment target sits among peer trials

522 716th of 2000 higher than 1,284 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01016808, the US trial registry maintained by the National Library of Medicine. NCT01016808 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.