Hallux ValgusPhase 2NCT00388011
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
A Phase 2 study testing Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg and Intranasal morphine (MNS075) 7.5 mg in people with Hallux Valgus, run by Javelin Pharmaceuticals.
Trial summary
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg and Intranasal morphine (MNS075) 7.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Aug 2005
- 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
- Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
- 18 years of age or older
- Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery
Who cannot join
- Allergy to shellfish
- Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
- Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
- Additional Inclusion/Exclusion Criteria May Apply
About this study
Official title: Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.
Read the detailed description
Diagnosis and Main Criteria for Inclusion:
Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.
- Conditions
- Hallux Valgus
- Being tested
- Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg, Intranasal morphine (MNS075) 7.5 mg, Intranasal morphine (MNS075) 15 mg, Intranasal morphine (MNS075) 30 mg
- Keywords
- Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine
- Medical subject headings
- Hallux Valgus, Pain, Postoperative, Hammer Toe Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Morphine (MNS075) 3.75 mgDrug
Intranasal Morphine (MNS075) 3.75 mg
Intravenous Morphine 7.5 mgDrug
Intravenous Morphine 7.5 mg
Intranasal morphine (MNS075) 7.5 mgDrug
Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 15 mgDrug
Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 30 mgDrug
Intranasal morphine (MNS075) 30 mg
Intranasal placeboDrug
Intranasal placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intranasal morphine 3.75 mg Receives: Drug: Intranasal Morphine (MNS075) 3.75 mg |
| 2 | Experimental | Intranasal morphine 7.5 mg Receives: Drug: Intranasal morphine (MNS075) 7.5 mg |
| 3 | Experimental | Intranasal morphine 15 mg Receives: Drug: Intranasal morphine (MNS075) 15 mg |
| 4 | Experimental | Intranasal morphine 30 mg Receives: Drug: Intranasal morphine (MNS075) 30 mg |
| 5 | Active comparator | Intravenous morphine 7.5 mg Receives: Drug: Intravenous Morphine 7.5 mg |
| 6 | Placebo comparator | Intranasal placebo Receives: Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Total Pain Relief 0-4 hours (TOTPAR4)
Measured: 4 hours
Secondary outcomes (1)
Other measures of pain relief
Measured: Several time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Douglas G Stoker, DPM, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388011
- Sponsor's protocol ID
- MOR-002
- Status last verified
- Jan 2008
- First submitted
- 12 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, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT00388011
- Acronym / sponsor ID
- MOR-002
- Conditions
- Hallux Valgus
- Keywords
- Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 13 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.
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.
Detailed description
Diagnosis and Main Criteria for Inclusion:
Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.
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 |
|---|---|---|
| 1 | Experimental | Drug: Intranasal Morphine (MNS075) 3.75 mgIntranasal morphine 3.75 mg |
| 2 | Experimental | Drug: Intranasal morphine (MNS075) 7.5 mgIntranasal morphine 7.5 mg |
| 3 | Experimental | Drug: Intranasal morphine (MNS075) 15 mgIntranasal morphine 15 mg |
| 4 | Experimental | Drug: Intranasal morphine (MNS075) 30 mgIntranasal morphine 30 mg |
| 5 | Active comparator | Drug: Intravenous Morphine 7.5 mgIntravenous morphine 7.5 mg |
| 6 | Placebo comparator | Drug: Intranasal placeboIntranasal placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
- 18 years of age or older
- Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery
Key exclusion criteria (4 listed)
- Allergy to shellfish
- Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
- Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
- Additional 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 Morphine (MNS075) 3.75 mgIntranasal Morphine (MNS075) 3.75 mg | Drug | 1 |
| Intravenous Morphine 7.5 mgIntravenous Morphine 7.5 mg | Drug | 5 |
| Intranasal morphine (MNS075) 7.5 mgIntranasal morphine (MNS075) 7.5 mg | Drug | 2 |
| Intranasal morphine (MNS075) 15 mgIntranasal morphine (MNS075) 15 mg | Drug | 3 |
| Intranasal morphine (MNS075) 30 mgIntranasal morphine (MNS075) 30 mg | Drug | 4 |
| Intranasal placeboIntranasal placebo | Drug | 6 |
Primary outcome
VAS Total Pain Relief 0-4 hours (TOTPAR4)
Time frame: 4 hours
1 secondary outcome
Other measures of pain relief
Time frame: Several time points
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.
Douglas G Stoker, DPM principal investigator
Jean Brown Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg and Intranasal morphine (MNS075) 7.5 mg in people with Hallux Valgus, run by Javelin Pharmaceuticals.
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 4 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.
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 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?
VAS Total Pain Relief 0-4 hours (TOTPAR4) (time frame: 4 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 14 Jan 2008.