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NCT01055015 · ClinicalTrials.gov registry record · Phase 3

Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty

A Phase 3 study, sponsored by QRxPharma.

Completed
Registry status
Phase 3
Development phase
141
Enrollment target

NCT01055015: Completed Phase 3 study, sponsored by QRxPharma.

NCT01055015 is a Phase 3 study that has completed, run by QRxPharma. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01055015, a Phase 3 study, has completed, sponsored by QRxPharma.

COMPLETED
Registry status
Phase 3
Development phase
141 participants
Enrollment target

Study Summary

This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty

Interventions

  • DRUG Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)
  • DRUG Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)

Trial Details

FieldValue
Enrollment Target 141 participants
Start Date 2010-02
Est. Completion 2010-12
Phase Phase 3
QRxPharma

7 total trials

What the finished NCT01055015 record still lists

NCT01055015 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) is the first listed.

NCT01055015 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01055015 about?

NCT01055015 is a clinical study titled "Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty". This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty

What is the current status of trial NCT01055015?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2010-02. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01055015?

The interventions under investigation include: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) (DRUG), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) (DRUG).

Who is sponsoring clinical trial NCT01055015?

This trial is sponsored by QRxPharma, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01055015's enrollment target sits among peer trials

141 1563rd of 2000 higher than 436 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 NCT01055015, the US trial registry maintained by the National Library of Medicine. NCT01055015 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.