Pain, PostoperativePhase 3NCT00390039
Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery
A Phase 3 study testing Intranasal Morphine and IV morphine in people with Pain, Postoperative, run by Javelin Pharmaceuticals at 7 sites in United States.
Trial summary
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intranasal Morphine and IV morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2006to Sep 2006
- 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
- Over 18 years old
- Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
- Moderate to severe pain within 8 hours following completion of the required surgery
Who cannot join
- Previous anaphylactic or serious allergic reaction to shellfish or opioids
- History of sleep apnea
- Other Inclusion/Exclusion Criteria May Apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
SCIREX Corporation
Austin, Texas, 78705
Vertex Clinical Research
Bakersfield, California, 93311
Arizona Research Center
Phoenix, Arizona, 85023
HOPE Research Institute
Phoenix, Arizona, 85050
Jean Brown Research
Salt Lake City, Utah, 84124
SCIREX Corporation
San Marcos, Texas, 78666
University Orthopedics Center
State College, Pennsylvania, 16801
About this study
Official title: Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
Read the detailed description
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
- Conditions
- Pain, Postoperative
- Being tested
- Intranasal Morphine, Placebo, IV morphine
- Keywords
- Pain, postoperative, Surgery, orthopedic, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal MorphineDrug
MNS075 7.5mg q1h PRN
PlaceboDrug
IN Placebo q1h PRN
IV morphineDrug
IV morphine 7.5mg q3h PRN
PlaceboDrug
IV Placebo q3h PRN
Intranasal morphineDrug
MNS075 15mg q3h PRN
PlaceboDrug
IN Placebo q3h PRN
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | MNS075 7.5mg Receives: Drug: Intranasal Morphine |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
| C | Active comparator | IV Morphine Receives: Drug: IV morphine |
| E | Experimental | MNS075 15mg Receives: Drug: Intranasal morphine |
| D | Placebo comparator | Placebo Receives: Drug: Placebo |
| F | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
Measured: Multiple
Secondary outcomes (1)
Other measures of pain
Measured: Multiple
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javelin Pharmaceuticals, Study director, Javelin Pharmacueticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390039
- Sponsor's protocol ID
- MOR-003
- Status last verified
- Jan 2008
- First submitted
- 17 Oct 2006
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT00390039
- Acronym / sponsor ID
- MOR-003
- Conditions
- Pain, Postoperative
- Keywords
- Pain, postoperative, Surgery, orthopedic, Morphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Oct 2006 (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.
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
Detailed description
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Intranasal MorphineMNS075 7.5mg |
| B | Placebo comparator | Drug: PlaceboPlacebo |
| C | Active comparator | Drug: IV morphineIV Morphine |
| E | Experimental | Drug: Intranasal morphineMNS075 15mg |
| D | Placebo comparator | Drug: PlaceboPlacebo |
| F | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
- Moderate to severe pain within 8 hours following completion of the required surgery
Key exclusion criteria (3 listed)
- Previous anaphylactic or serious allergic reaction to shellfish or opioids
- History of sleep apnea
- Other Inclusion/Exclusion Criteria May Apply
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 |
|---|---|---|
| Intranasal MorphineMNS075 7.5mg q1h PRN | Drug | A |
| PlaceboIN Placebo q1h PRN | Drug | B |
| IV morphineIV morphine 7.5mg q3h PRN | Drug | C |
| PlaceboIV Placebo q3h PRN | Drug | D |
| Intranasal morphineMNS075 15mg q3h PRN | Drug | E |
| PlaceboIN Placebo q3h PRN | Drug | F |
Primary outcome
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
Time frame: Multiple
1 secondary outcome
Other measures of pain
Time frame: Multiple
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 14 Jan 2008.
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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.
Javelin Pharmaceuticals study director
Javelin Pharmacueticals
7 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 Intranasal Morphine and IV morphine in people with Pain, Postoperative, run by Javelin Pharmaceuticals at 7 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 3 inclusion and 3 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 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS) (time frame: Multiple). 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 14 Jan 2008.