Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction
