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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Placebo; Drug: ADL5859 30 mg; Drug: ADL5859 100 mg; Drug: ADL5859 200 mg; Drug: ibuprofen 400 mg

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Scirex Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; single dose
Experimental: ADL5859 30 mg	Drug: ADL5859 30 mg; single dose
Experimental: ADL5859 100 mg	Drug: ADL5859 100 mg; single dose
Experimental: ADL5859 200 mg	Drug: ADL5859 200 mg; single dose
Active Comparator: ibuprofen 400 mg	Drug: ibuprofen 400 mg; single dose; Other Names: Advil

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cubist Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: October 9, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: dental pain; delta opioid agonist
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 33CL230