Post-Operative PainPhase 2NCT00390312
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
A Phase 2 study testing Intranasal Morphine 15 mg, Immediate Release Oral Morphine 60 mg and Intravenous morphine in people with Post-Operative Pain and Third Molar Extraction, run by Javelin Pharmaceuticals.
Trial summary
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post-Operative Pain, Third Molar Extraction
- What is being tested?
- Intranasal Morphine 15 mg, Immediate Release Oral Morphine 60 mg and Intravenous morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Nov 2001
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female 18-40 years of age
- Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
- Moderate or severe pain within 6 hours of completion of surgery
Who cannot join
- Other oral surgical procedures during the same session except the removal of supernumerary third molars
- Evidence 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
- Allergy to shellfish
- Additional Inclusion/Exclusion Criteria May Apply
About this study
Official title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.
Read the detailed description
Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).
- Conditions
- Post-Operative Pain, Third Molar Extraction
- Being tested
- Intranasal Placebo, Intranasal Morphine 15 mg, Immediate Release Oral Morphine 60 mg, Intravenous morphine, Intranasal morphine 7.5 mg
- Keywords
- Post operative pain, Third molar extraction, Dental surgery, 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 PlaceboDrug
Intranasal placebo
Intranasal Morphine 15 mgDrug
Intranasal Morphine 15 mg
Immediate Release Oral Morphine 60 mgDrug
Immediate Release Oral Morphine 60 mg
Intravenous morphineDrug
Intravenous morphine 7.5 mg
Intranasal morphine 7.5 mgDrug
Intranasal morphine 7.5 mg
Oral placeboDrug
Oral placebo
Intravenous placeboDrug
Intravenous placebo
| Study group | Role | What they receive |
|---|---|---|
| 4 | Active comparator | Intravenous morphine Receives: Drug: Intravenous morphine |
| 1 | Experimental | Intranasal morphine 7.5 mg Receives: Drug: Intranasal morphine 7.5 mg |
| 2 | Experimental | Intranasal morphine 15 mg Receives: Drug: Intranasal Morphine 15 mg |
| 3 | Active comparator | Oral morphine 60 mg Receives: Drug: Immediate Release Oral Morphine 60 mg |
| 5 | Placebo comparator | Intranasal placebo Receives: Drug: Intranasal Placebo |
| 6 | Placebo comparator | Oral placebo Receives: Drug: Oral placebo |
| 7 | Placebo comparator | Intravenous placebo Receives: Drug: Intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
Measured: 2 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 posted19 Oct 2006 (estimated)
- Study startSep 2001
- Primary completionNov 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyle Christensen, DDS, Principal investigator, Jean Brown Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390312
- Sponsor's protocol ID
- MOR-001
- Status last verified
- Dec 2007
- First submitted
- 17 Oct 2006
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
- ClinicalTrials.gov ID
- NCT00390312
- Acronym / sponsor ID
- MOR-001
- Conditions
- Post-Operative Pain, Third Molar Extraction
- Keywords
- Post operative pain, Third molar extraction, Dental surgery, Morphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Nov 2001 (actual)
- Study completion
- Nov 2001 (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.
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.
Detailed description
Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 4 | Active comparator | Drug: Intravenous morphineIntravenous morphine |
| 1 | Experimental | Drug: Intranasal morphine 7.5 mgIntranasal morphine 7.5 mg |
| 2 | Experimental | Drug: Intranasal Morphine 15 mgIntranasal morphine 15 mg |
| 3 | Active comparator | Drug: Immediate Release Oral Morphine 60 mgOral morphine 60 mg |
| 5 | Placebo comparator | Drug: Intranasal PlaceboIntranasal placebo |
| 6 | Placebo comparator | Drug: Oral placeboOral placebo |
| 7 | Placebo comparator | Drug: Intravenous placeboIntravenous placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female 18-40 years of age
- Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
- Moderate or severe pain within 6 hours of completion of surgery
Key exclusion criteria (5 listed)
- Other oral surgical procedures during the same session except the removal of supernumerary third molars
- Evidence 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
- Allergy to shellfish
- 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 PlaceboIntranasal placebo | Drug | 5 |
| Intranasal Morphine 15 mgIntranasal Morphine 15 mg | Drug | 2 |
| Immediate Release Oral Morphine 60 mgImmediate Release Oral Morphine 60 mg | Drug | 3 |
| Intravenous morphineIntravenous morphine 7.5 mg | Drug | 4 |
| Intranasal morphine 7.5 mgIntranasal morphine 7.5 mg | Drug | 1 |
| Oral placeboOral placebo | Drug | 6 |
| Intravenous placeboIntravenous placebo | Drug | 7 |
Primary outcome
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
Time frame: 2 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 4 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.
Kyle Christensen, DDS principal investigator
Jean Brown Associates, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Morphine 15 mg, Immediate Release Oral Morphine 60 mg and Intravenous morphine in people with Post-Operative Pain and Third Molar Extraction, 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 5 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 4 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?
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours (time frame: 2 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 4 Jan 2008.