Postoperative PainPhase 3NCT01280331
Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients
A Phase 3 study testing Q8003 (morphine sulfate and oxycodone hydrochloride), Morphine sulfate and Oxycodone HCl in people with Postoperative Pain, run by QRxPharma Inc. at 4 sites in United States.
Trial summary
This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery. 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), Morphine sulfate and Oxycodone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Apr 2011
- 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
- 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 4 or more on the 11 point NPRS scale).
- At least 40% of study subjects will be 60 years of age or older.
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 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 acetaminophen.
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigational site
Anaheim, California, 92801
Investigational site
Owings Mills, Maryland, 21117
Investigational site
Pasadena, Maryland, 21122
Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Effects of Q8003 to the Morphine-Equivalent Doses of Oxycodone and of Morphine on the Opioid-Related Adverse Events of Moderate to Severe Nausea, Emesis, and Dizziness in Subjects With Acute Moderate-to-Severe Postoperative Pain Following Bunionectomy Surgery
This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.
- Conditions
- Postoperative Pain
- Being tested
- Q8003 (morphine sulfate and oxycodone hydrochloride), Morphine sulfate, Oxycodone HCl
- Keywords
- Bunionectomy
- 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
Two Q8003 6 mg/4 mg IR Capsules q6h
Morphine sulfateDrug
Two morphine sulfate 12 mg IR capsules q6h
Oxycodone HClDrug
Two oxycodone HCl 8 mg IR Capsules q6h
| Study group | Role | What they receive |
|---|---|---|
| Q8003 12 mg/8 mg | Experimental | Combination Receives: Drug: Q8003 (morphine sulfate and oxycodone hydrochloride) |
| Morphine sulfate 24 mg | Active comparator | Single component Receives: Drug: Morphine sulfate |
| Oxycodone HCl 16 mg | Active comparator | Single component Receives: Drug: Oxycodone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in desaturation events per standardized time unit
Measured: 48 hours
Secondary outcomes (2)
Difference in efficacy between Q8003 and its components (morphine and oxycodone)
Changes from baseline in pain intensity
Measured: 48 hours
Differences in the absence of emesis without the use of an anti-emetic (emesis complete response)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
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
- 375 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
- NCT01280331
- Sponsor's protocol ID
- Q8003-022
- Status last verified
- May 2012
- First submitted
- 18 Jan 2011
- 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, Multi-Center, Repeat-Dose, Comparison of the Effects of Q8003 to the Morphine-Equivalent Doses of Oxycodone and of Morphine on the Opioid-Related Adverse Events of Moderate to Severe Nausea, Emesis, and Dizziness in Subjects With Acute Moderate-to-Severe Postoperative Pain Following Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT01280331
- Acronym / sponsor ID
- Q8003-022
- Conditions
- Postoperative Pain
- Keywords
- Bunionectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- QRxPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jan 2011 (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 randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Q8003 12 mg/8 mg | Experimental | Drug: Q8003 (morphine sulfate and oxycodone hydrochloride)Combination |
| Morphine sulfate 24 mg | Active comparator | Drug: Morphine sulfateSingle component |
| Oxycodone HCl 16 mg | Active comparator | Drug: Oxycodone HClSingle component |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 4 or more on the 11 point NPRS scale).
- At least 40% of study subjects will be 60 years of age or older.
Key exclusion criteria (7 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 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 acetaminophen.
- 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)Two Q8003 6 mg/4 mg IR Capsules q6h | Drug | Q8003 12 mg/8 mg |
| Morphine sulfateTwo morphine sulfate 12 mg IR capsules q6h | Drug | Morphine sulfate 24 mg |
| Oxycodone HClTwo oxycodone HCl 8 mg IR Capsules q6h | Drug | Oxycodone HCl 16 mg |
Primary outcome
Differences in desaturation events per standardized time unit
Time frame: 48 hours
2 secondary outcomes
Difference in efficacy between Q8003 and its components (morphine and oxycodone)
Time frame: 48 hours
Differences in the absence of emesis without the use of an anti-emetic (emesis complete response)
Time frame: 48 hours
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.
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 3 study testing Q8003 (morphine sulfate and oxycodone hydrochloride), Morphine sulfate and Oxycodone HCl 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 7 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 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?
Differences in desaturation events per standardized time unit (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.