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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 is a Phase 3 study of Postoperative Pain that has completed, run by QRxPharma. The registered enrollment target is 375 participants, above the 225-participant average among 63 other Postoperative Pain trials with a reported enrollment target (67% higher). The trial reports 4 study locations across 3 states.

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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

FieldValue
Enrollment Target 375 participants
Start Date 2011-01
Est. Completion 2011-04
Phase Phase 3

Sponsor

QRxPharma

7 total trials

What the Registry Record Tells You About NCT01280331

The ClinicalTrials.gov registry entry for NCT01280331 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 225-participant average among 63 other Postoperative Pain trials with a reported enrollment target (67% higher). The listed sponsor is QRxPharma, which has 7 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.