Postoperative PainPhase 2NCT00818493
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
A Phase 2 study testing Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Percocet (oxycodone and acetaminophen) in people with Postoperative Pain, run by QRxPharma Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Percocet (oxycodone and acetaminophen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2009to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
West Alabama Research, Inc.
Birmingham, Alabama, 35209
Research Concepts, Ltd.
Houston, Texas, 77024
Arizona Research Center
Phoenix, Arizona, 85023
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
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
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.
Read the detailed 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.
- Conditions
- Postoperative Pain
- Being tested
- Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride), Percocet (oxycodone and acetaminophen)
- Keywords
- total knee arthroplasty, total hip arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q8003 (morphine sulfate and oxycodone hydrochloride)Drug
IR Capsules, ascending flexible dose, every 4 to 6 hours
Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)Drug
One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours
Percocet (oxycodone and acetaminophen)Drug
One or two 5mg/325 mg tablets every 4 to 6 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Q8003, flexible ascending dose Receives: Drug: Q8003 (morphine sulfate and oxycodone hydrochloride) |
| 2 | Experimental | Low dose Q8003 Receives: Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) |
| 3 | Active comparator | Percocet (oxycodone and acetaminophen) Receives: Drug: Percocet (oxycodone and acetaminophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain intensity scores from baseline
Measured: 48 hours
Secondary outcomes (1)
Safety: adverse events
Measured: Throughout the 48 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- QRxPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia T. Richards, MD, Ph.D., Study director, QRxPharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818493
- Sponsor's protocol ID
- Q8003-020
- Status last verified
- May 2012
- First submitted
- 6 Jan 2009
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Richards P, Gimbel JS, Minkowitz HS, Kelen R, Stern W. Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty. Clin Ther. 2013 Apr;35(4):498-511. doi: 10.1016/j.clinthera.2013.03.002. Epub 2013 Mar 29.
PubMed 23545428
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00818493
- Acronym / sponsor ID
- Q8003-020
- Conditions
- Postoperative Pain
- Keywords
- total knee arthroplasty, total hip arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- QRxPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)Q8003, flexible ascending dose |
| 2 | Experimental | Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)Low dose Q8003 |
| 3 | Active comparator | Drug: Percocet (oxycodone and acetaminophen)Percocet (oxycodone and acetaminophen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q8003 (morphine sulfate and oxycodone hydrochloride)IR Capsules, ascending flexible dose, every 4 to 6 hours | Drug | 1 |
| Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours | Drug | 2 |
| Percocet (oxycodone and acetaminophen)One or two 5mg/325 mg tablets every 4 to 6 hours | Drug | 3 |
Primary outcome
Difference in pain intensity scores from baseline
Time frame: 48 hours
1 secondary outcome
Safety: adverse events
Time frame: Throughout the 48 hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
- Derived from this study: PubMed 23545428Richards P, Gimbel JS, Minkowitz HS, Kelen R, Stern W. Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty. Clin Ther. 2013 Apr;35(4):498-511. doi: 10.1016/j.clinthera.2013.03.002. Epub 2013 Mar 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia T. Richards, MD, Ph.D. study director
QRxPharma Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Percocet (oxycodone and acetaminophen) in people with Postoperative Pain, run by QRxPharma Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain intensity scores from baseline (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.