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

Q

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

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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