Dental PainPhase 2NCT00945763
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
A Phase 2 study testing N1539 and Motrin in people with Dental Pain, run by Alkermes, Inc. at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Pain
- What is being tested?
- N1539 and Motrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction
Who cannot join
- allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
- use of aspirin or other analgesics within 48 hours prior to surgery
- current or recent history of drug or alcohol abuse
- any medication for treatment of chronic pain
- clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
- prior abdominal surgery, except uncomplicated appendectomy
Show all 9Show fewer
- any other surgical procedure within 30 days before administration of study drug
- pregnancy or breastfeeding
- untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.
- Conditions
- Dental Pain
- Being tested
- N1539, placebo, Motrin
- Keywords
- Dental Pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
Also called meloxicam
30 mg
placeboDrug
Also called sugar pill
tablets
N1539Drug
Also called meloxicam
15 mg
N1539Drug
Also called meloxicam
60 mg
MotrinDrug
Also called ibuprofen
400 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| N1539 15 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 30 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 60 mg | Experimental | Not described Receives: Drug: N1539 |
| Motrin | Active comparator | Not described Receives: Drug: Motrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Difference at End of Study
Measured: 0-24 hours
Secondary outcomes (1)
Onset of action
Measured: 0-1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Christensen, DDS, Principal investigator, Jean Brown Research, Salt Lake City, UT 84124
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945763
- Sponsor's protocol ID
- N1539-02
- Status last verified
- Nov 2011
- First submitted
- 23 Jul 2009
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
PubMed 30737315Christensen SE, Cooper SA, Mack RJ, McCallum SW, Du W, Freyer A. A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery. J Clin Pharmacol. 2018 May;58(5):593-605. doi: 10.1002/jcph.1058. Epub 2018 Jan 12.
PubMed 29329493
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
- ClinicalTrials.gov ID
- NCT00945763
- Acronym / sponsor ID
- N1539-02
- Conditions
- Dental Pain
- Keywords
- Dental Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Jul 2009 (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.
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Detailed description
This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| N1539 15 mg | Experimental | Drug: N1539 |
| N1539 30 mg | Experimental | Drug: N1539 |
| N1539 60 mg | Experimental | Drug: N1539 |
| Motrin | Active comparator | Drug: Motrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction
Key exclusion criteria (9 listed)
- allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
- use of aspirin or other analgesics within 48 hours prior to surgery
- current or recent history of drug or alcohol abuse
- any medication for treatment of chronic pain
- clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
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 |
|---|---|---|
| N1539Also: meloxicam30 mg | Drug | N1539 30 mg |
| placeboAlso: sugar pilltablets | Drug | placebo |
| N1539Also: meloxicam15 mg | Drug | N1539 15 mg |
| N1539Also: meloxicam60 mg | Drug | N1539 60 mg |
| MotrinAlso: ibuprofen400 mg | Drug | Motrin |
Primary outcome
Pain Intensity Difference at End of Study
Time frame: 0-24 hours
1 secondary outcome
Onset of action
Time frame: 0-1 hour
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 2 Dec 2011.
- Derived from this study: PubMed 30737315Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
- Derived from this study: PubMed 29329493Christensen SE, Cooper SA, Mack RJ, McCallum SW, Du W, Freyer A. A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery. J Clin Pharmacol. 2018 May;58(5):593-605. doi: 10.1002/jcph.1058. Epub 2018 Jan 12.
- Study siteLink provided by the sponsor.
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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.
Steven Christensen, DDS principal investigator
Jean Brown Research, Salt Lake City, UT 84124
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N1539 and Motrin in people with Dental Pain, run by Alkermes, Inc. at 1 site 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 1 inclusion and 9 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Pain Intensity Difference at End of Study (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945763, which also lists 2 linked publications.
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 2 Dec 2011.