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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QRxPharma Inc.
ClinicalTrials.gov Identifier:
NCT00560183
First received: November 14, 2007
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Randomized, Double-blind Study of the Safety and Efficacy of Q8003 in the Management of Post-bunionectomy Pain

Resource links provided by NLM:


Further study details as provided by QRxPharma Inc.:

Primary Outcome Measures:
  • Difference in pain intensity scores from baseline [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appropriate dosing interval for each tested dose level [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Safety: incidence of opioid-related adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)
Capsules, four different mg dosage strengths
Placebo Comparator: 2 Drug: Placebo
Capsules

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560183

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Pennsylvania
Advanced Regional Center for Foot and Ankle Care
Altoona, Pennsylvania, United States, 16602
United States, Texas
Scirex Research Center
Houston, Texas, United States, 77081
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
QRxPharma Inc.
Investigators
Study Director: Warren Stern, Ph.D. QRxPharma Inc.
  More Information

No publications provided

Responsible Party: QRxPharma Inc.
ClinicalTrials.gov Identifier: NCT00560183     History of Changes
Other Study ID Numbers: Q8003-007
Study First Received: November 14, 2007
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:
Acute
Bunionectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014