Postoperative PainPhase 3NCT01055015
Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty
A Phase 3 study testing Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) in people with Postoperative Pain, run by QRxPharma Inc. at 11 sites in United States.
Trial summary
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee 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?
- Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 3
- 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
- At least 18 years of age at time of enrollment.
- If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, 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 performed under 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 and 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 10Show 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.
- History of sleep apnea.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Investigator Site
Birmingham, Alabama, 35209
Investigator Site
Edgewater, Florida, 32132
Investigator Site
Englewood, Colorado, 80110
Investigator Site
Houston, Texas, 77024
Investigator Site
Laguna Hills, California, 92653
Investigator Site
Long Beach, California, 90806
Investigator Site
Miami, Florida, 33136
Investigator Site
Pasadena, California, 91105
Investigator Site
Phoenix, Arizona, 85023
Investigator Site
Sarasota, Florida, 34232
Investigator Site
Sheffield, Alabama, 35660
About this study
Official title: A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
Read the detailed description
This Phase 3 study is a two-arm, double-blind study to:
- compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.
- to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.
- Conditions
- Postoperative Pain
- Being tested
- Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride), Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)
- Keywords
- total knee 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.
Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)Drug
IR Capsules, flexible dose, every 4 to 6 hours
Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)Drug
One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Q8003, Flexible dose Receives: Drug: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) |
| 2 | Experimental | Q8003, Low dose Receives: Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) |
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, opioid-related signs and symptoms
Measured: Throughout the 48-hour period and during the voluntary safety extension period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- QRxPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055015
- Sponsor's protocol ID
- Q8003-009
- Status last verified
- May 2012
- First submitted
- 22 Jan 2010
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
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
- A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01055015
- Acronym / sponsor ID
- Q8003-009
- Conditions
- Postoperative Pain
- Keywords
- total knee arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- QRxPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jan 2010 (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 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
Detailed description
This Phase 3 study is a two-arm, double-blind study to:
- compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.
- to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)Q8003, Flexible dose |
| 2 | Experimental | Drug: Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)Q8003, Low dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age at time of enrollment.
- If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, 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 performed under 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 and at least 4 on the 11 point NPRS scale within 6 hours of discontinuing PCA on the morning after surgery).
Key exclusion criteria (10 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 |
|---|---|---|
| Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)IR Capsules, flexible dose, every 4 to 6 hours | Drug | 1 |
| Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose. | Drug | 2 |
Primary outcome
Difference in pain intensity scores from baseline
Time frame: 48 hours
1 secondary outcome
Safety: adverse events, opioid-related signs and symptoms
Time frame: Throughout the 48-hour period and during the voluntary safety extension 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride) and Low dose Q8003 (morphine sulfate and oxycodone hydrochloride) in people with Postoperative Pain, run by QRxPharma Inc. at 11 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 10 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 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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.