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

QRxPharma

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Oxycodone HCl 4mg; Drug: Morphine sulfate; Drug: Oxycodone HCl; Drug: Q8003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00831051

Q8003-021

Details and patient eligibility

About

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 > 2 months 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 6 patient groups

Q8003 12mg/8mg

Experimental group

Description:

Combination

Treatment:

Drug: Q8003

Drug: Q8003

Morphine sulfate 12 mg

Active Comparator group

Description:

Single component

Treatment:

Drug: Morphine sulfate

Drug: Morphine sulfate

Oxycodone HCl 8mg

Active Comparator group

Description:

Single component

Treatment:

Drug: Oxycodone HCl

Q8003 6mg/4mg

Experimental group

Description:

Combination

Treatment:

Drug: Q8003

Drug: Q8003

Morphine sulfate 6mg

Active Comparator group

Description:

Single component

Treatment:

Drug: Morphine sulfate

Drug: Morphine sulfate

Oxycodone HCl 4mg

Active Comparator group

Description:

Single component

Treatment:

Drug: Oxycodone HCl 4mg