Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
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
1 other identifier
interventional
230
1 country
1
Brief Summary
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 2, 2011
November 1, 2011
4 months
July 23, 2009
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Intensity Difference at End of Study
0-24 hours
Secondary Outcomes (1)
Onset of action
0-1 hour
Study Arms (5)
placebo
PLACEBO COMPARATORN1539 15 mg
EXPERIMENTALN1539 30 mg
EXPERIMENTALN1539 60 mg
EXPERIMENTALMotrin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- surgical extraction of \> 2 third molars with at least 1 complete or partial mandibular bony extraction
You may not qualify if:
- 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
- any other surgical procedure within 30 days before administration of study drug
- pregnancy or breastfeeding
- untreated hypertension; SBP \> 140 mmHg or DBP \> 95 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (2)
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.
PMID: 30737315DERIVEDChristensen 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.
PMID: 29329493DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Christensen, DDS
Jean Brown Research, Salt Lake City, UT 84124
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
December 2, 2011
Record last verified: 2011-11