Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Single-Dose, Double-Blind, Active- and Placebo-Controlled Study of ADL5859 for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: ADL5859 30 mg
* Drug: ADL5859 100 mg
* Drug: ADL5859 200 mg
* Drug: ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single dose<br>|
| Experimental: ADL5859 30 mg<br> | Drug: ADL5859 30 mg<br>* single dose<br>|
| Experimental: ADL5859 100 mg<br> | Drug: ADL5859 100 mg<br>* single dose<br>|
| Experimental: ADL5859 200 mg<br> | Drug: ADL5859 200 mg<br>* single dose<br>|
| Active Comparator: ibuprofen 400 mg<br> | Drug: ibuprofen 400 mg<br>* single dose<br>* Other names: Advil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pain relief 0-4 hours after study medication |  | 4 hours after study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delta opioid agonist, dental pain