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

• Sponsor: QRxPharma Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00831051
• Collaborator: (none)
• Enrollment: 197
• Locations: 6
• Arms: 6
• Duration (Months): 2
• Patients Per Site: 32.8
• Patients Per Site Per Month: 16.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Q8003; Drug: Morphine sulfate; Drug: Oxycodone HCl; Drug: Q8003; Drug: Morphine sulfate; Drug: Oxycodone HCl 4mg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Q8003 12mg/8mg Combination	Drug: Q8003; One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
Active Comparator: Morphine sulfate 12 mg Single component	Drug: Morphine sulfate; One morphine sulfate 12mg IR capsule q6h
Active Comparator: Oxycodone HCl 8mg Single component	Drug: Oxycodone HCl; One oxycodone HCl 8mg IR Capsule q6h
Experimental: Q8003 6mg/4mg Combination	Drug: Q8003; One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
Active Comparator: Morphine sulfate 6mg Single component	Drug: Morphine sulfate; Two morphine sulfate 3mg IR capsules q6h
Active Comparator: Oxycodone HCl 4mg Single component	Drug: Oxycodone HCl 4mg; Two oxycodone HCl 2mg IR Capsules q6h

Outcome Measures

Primary Outcome Measures

1. Difference in pain intensity scores from baseline [48 hours]

Secondary Outcome Measures

1. Safety: adverse events [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associated Foot and Ankle Specialists	Phoenix	Arizona	United States	85050
2	Advanced Clinical Research Institute	Anaheim	California	United States	92801
3	Crossroads Research, Inc.	Owings Mills	Maryland	United States	21117
4	Chesapeake Foot and Ankle	Pasadena	Maryland	United States	21122
5	Advanced Regional Center for Ankle and Foot Care	Altoona	Pennsylvania	United States	92801
6	Jean Brown Research	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• QRxPharma Inc.

Investigators

• Study Director: Patricia T. Richards, MD, Ph.D., QRxPharma Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: QRxPharma Inc.
• ClinicalTrials.gov Identifier: NCT00831051
• Other Study ID Numbers: Q8003-021
• First Posted: Jan 28, 2009
• Last Update Posted: May 17, 2012
• Last Verified: May 1, 2012

• Keywords provided by QRxPharma Inc.: Bunionectomy
• Additional relevant MeSH terms: Pain, Postoperative; Morphine; Oxycodone

Study Results

No Results Posted as of May 17, 2012