Acute Pain
Conditions
Keywords
delta opioid agonist, dental pain
Brief summary
The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.
Interventions
DRUGPlacebo
single dose
DRUGADL5859 30 mg
single dose
DRUGADL5859 100 mg
single dose
DRUGADL5859 200 mg
single dose
DRUGibuprofen 400 mg
single dose
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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 50 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * have 2 or more 3rd molars requiring extraction, including at least 1 partially or completely bone-impacted mandibular molar * experience moderate to severe pain intensity as measured by the Numeric Pain Rating Scale (NPRS) (score ≥ 5) within 6 hours after surgery * for male subjects, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive * for female subjects, be using contraceptives, be postmenopausal, or have undergone hysterectomy or tubal ligation * be able to take oral study medications Key
Exclusion criteria
* have positive results either on the urine screening tests for opiates, tetrahydrocannabinol,cocaine, amphetamines, barbiturates, benzodiazepines, phencyclidine, or propoxyphene or on the alcohol breathalyzer test * have a history of alcoholism or drug addiction or abuse within 5 years before dosing with study medication * have a history of chronic use (defined as daily use for \> 2 weeks) of glucocorticoids,nonsteroidal anti-inflammatory drugs, or opiates for any condition within 6 months of study medication administration * have a known allergy or history of significant reaction to any of the known treatment medications (ADL5859-like compounds or ibuprofen) or rescue pain medication (acetaminophen) * have significant renal or hepatic disease, as indicated by clinical laboratory assessment * have a known history of epilepsy or seizure disorder, including history of febrile seizure, or any other medical or psychiatric condition that, in the judgment of the investigator, would put the subject at risk while in the study, could influence the results of the study, or could negatively affect the subject's ability to participate in the study * have a history or evidence of orthostatic hypotension at screening have a history of significant head trauma (head injury with loss of consciousness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pain relief 0-4 hours after study medication | 4 hours after study medication |
Countries
United States
Outcome results
None listed