Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty

Postoperative Pain Clinical Trial

Official title:

An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818493
• Other study ID #: Q8003-020
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2009
• Last updated: May 15, 2012
• Start date: February 2009
• Est. completion date: July 2009

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 is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.

Description:

This Phase 2 study is a 3 arm, open-label pilot study to evaluate:

• the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially up to 6 mg/ 4mg) and to 1-2 Percocet® 5 mg/325 mg tablets. Study drug will be administered every 4-6 hours over a 48-hour Treatment Period to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.

• for the flexible ascending regimen of Q8003 treatment group, to evaluate the adequacy of the algorithm for conversion of IV PCA morphine to oral morphine equivalent doses of Q8003.

• the safety of the flexible ascending regimen of Q8003 administered over a 48-hour Treatment Period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male of female, at least 18 years of age at time of enrollment.

• If female, be at least one year post-menopausal, surgically sterile or practicing effective contraception, be non-lactating, and if of child-bearing potential, have a negative urine pregnancy test result.

• Have a body mass index (BMI) of 38 kg/m2 or less.

• Have undergone a primary unilateral total knee arthroplasty or total hip arthroplasty performed under standardized general, spinal or epidural anesthesia.

• Have developed 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 within 6 hours of discontinuing PCA on the morning after surgery).

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).

• History of abusing licit or illicit drug substances within five (5) years of study entry.

• Has taken drugs known to interact with morphine or oxycodone metabolism, including, but not limited to, phenothiazines, monoamine oxidase inhibitors (MAOI), amphetamines, and muscle relaxants within the 4 weeks prior to the date of surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Q8003 (morphine sulfate and oxycodone hydrochloride)
IR Capsules, ascending flexible dose, every 4 to 6 hours
• Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours
• Percocet (oxycodone and acetaminophen)
One or two 5mg/325 mg tablets every 4 to 6 hours

Locations

Country	Name	City	State
United States	West Alabama Research, Inc.	Birmingham	Alabama
United States	Research Concepts, Ltd.	Houston	Texas
United States	Arizona Research Center	Phoenix	Arizona
United States	William Beaumont Hospital	Royal Oak	Michigan

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	Safety: adverse events		Throughout the 48 hour period	Yes