Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Q8003 12 mg/8 mg

Combination

Group Type EXPERIMENTAL

Q8003

Intervention Type DRUG

Q8003 is a combination of morphine sulfate and oxycodone HCl

Morphine sulfate 12 mg

Single component

Group Type ACTIVE_COMPARATOR

Morphine sulfate

Intervention Type DRUG

One morphine sulfate 12 mg IR capsule q6h

Oxycodone HCl 8 mg

Single component

Group Type ACTIVE_COMPARATOR

Oxycodone HCl

Intervention Type DRUG

One oxycodone HCl 8 mg IR Capsule q6h

Interventions

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Q8003

Q8003 is a combination of morphine sulfate and oxycodone HCl

Intervention Type DRUG

Morphine sulfate

One morphine sulfate 12 mg IR capsule q6h

Intervention Type DRUG

Oxycodone HCl

One oxycodone HCl 8 mg IR Capsule q6h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is male or female and at least 18 years of age.
* Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
* Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
* To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or at least 4 on the 11 point NPRS scale).

Exclusion Criteria

* In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
* Used opiates continuously (including tramadol) for more than ten days in the past year.
* Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
* Currently receiving any medications that are not at a stable dose (the same dose for \> 4 weeks prior to date of surgery).
* Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
* Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
* Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No