Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

Postoperative Pain Clinical Trial

Official title:

A Placebo-controlled, Randomized, Double-blind Study of the Safety and Efficacy of Q8003 in the Management of Post-bunionectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560183
• Other study ID #: Q8003-007
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2007
• Last updated: May 15, 2012
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2012
• Source: QRxPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will explore the efficacy and safety of a fixed dose combination of morphine and oxycodone for management of acute postoperative pain. The study will explore the efficacy dose response and dosing interval required to maintain adequate analgesia at each tested dosage strength.

Description:

This study is a randomized, double-blind, placebo-controlled, rising-dose/by-cohort study of the efficacy and safety of Q8003 in inpatients with acute pain following unilateral bunionectomy surgery. Patients in each dosing group will receive either Q8003 (approximately 50 per dosing group) or placebo (approximately 13 per dosing group), determined by random sequential assignment and blinded to patients and managing Investigators. Dosing groups will be enrolled sequentially in ascending order; only one dosing group will be open at a time for enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is scheduled for bunionectomy surgery and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.

• 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).

• Patient has normal laboratory values or abnormal values judged not clinically significant by the Investigator for clinical chemistry and hematology (< 1.5 ULN).

• Patient is in general good health based on physical examination, medical history and clinically acceptable results for the following assessments: vital signs and a 12-lead electrocardiogram (ECG).

• Patient gives written informed consent and is able to understand the requirements of the study, adhere to the study restrictions, and be available for the required follow-up assessment.

Exclusion Criteria:

• Patient has a current acute or chronic disease that would interfere with evaluations of postoperative Q8003 efficacy or safety.

• Patient has a history of poor tolerance to short term opiate use in prior surgeries, based on patient self-report.

• Patient used opiates continuously (including tramadol) for more than five days in the past year.

• Patient has a history of pulmonary, cardiovascular, 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.

• Patient has positive HIV serology or signs of HIV infection or AIDS.

• Patient has positive HBsAg or HCV antibody.

• Patient is currently receiving any medications that are not at a stable dose (the same dose for >2 month prior to date of surgery).

• Patient is currently receiving muscle relaxants, antipsychotic drugs, monoamine oxidase inhibitors, or any medications for the treatment of depression.

• Patient has used systemic corticosteroids within previous fourteen (14) days.

• Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.

• Patient has 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).

• Patient has a history of abusing licit or illicit drug substances within five (5) years of study entry.

• Patient is obese with a body mass index >32.

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Q8003 (morphine sulfate and oxycodone hydrochloride)
Capsules, four different mg dosage strengths
• Placebo
Capsules

Locations

Country	Name	City	State
United States	Advanced Regional Center for Foot and Ankle Care	Altoona	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Scirex Research Center	Houston	Texas
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Jean Brown Research	Salt Lake City	Utah
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
QRxPharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain intensity scores from baseline		48 hours	No
Secondary	Appropriate dosing interval for each tested dose level		48 hours	No
Secondary	Safety: incidence of opioid-related adverse events		48 hours	No