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

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: ADL5859 30 mg; Drug: ADL5859 100 mg; Drug: ADL5859 200 mg; Drug: Placebo; Drug: ibuprofen 400 mg

• Registration Number: NCT00993863
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADL5859 30 mg	ADL5859 30 mg	-
ADL5859 100 mg	ADL5859 100 mg	-
ADL5859 200 mg	ADL5859 200 mg	-
Placebo	Placebo	-
ibuprofen 400 mg	ibuprofen 400 mg	-

Primary Outcome Measures

Name	Time	Method
Total pain relief 0-4 hours after study medication	4 hours after study medication

Trial Locations

Locations (1)

SCIREX Research Center; 🇺🇸 Austin, Texas, United States