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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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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

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No