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

Information source: QRxPharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Q8003 (Drug); Morphine sulfate (Drug); Oxycodone HCl (Drug); Q8003 (Drug); Morphine sulfate (Drug); Oxycodone HCl 4mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: QRxPharma Inc.

Official(s) and/or principal investigator(s):
Patricia T. Richards, MD, Ph.D., Study Director, Affiliation: QRxPharma Inc.

Summary

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.

Clinical Details

Official title: A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pain Following Bunionectomy Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Difference in pain intensity scores from baseline

Secondary outcome: Safety: adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Associated Foot and Ankle Specialists, Phoenix, Arizona 85050, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Crossroads Research, Inc., Owings Mills, Maryland 21117, United States

Chesapeake Foot and Ankle, Pasadena, Maryland 21122, United States

Advanced Regional Center for Ankle and Foot Care, Altoona, Pennsylvania 92801, United States

Jean Brown Research, Salt Lake City, Utah 84124, United States

Additional Information

Starting date: December 2008
Last updated: May 15, 2012

Page last updated: August 23, 2015

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