Dental Pain
Conditions
Keywords
Dental Pain
Brief summary
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.
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* surgical extraction of \> 2 third molars with at least 1 complete or partial mandibular bony extraction
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity Difference at End of Study | 0-24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Onset of action | 0-1 hour |
Countries
United States
Outcome results
None listed