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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Drug: ADL5859 100 mg; Drug: ibuprofen 400 mg; Drug: Placebo; Drug: ADL5859 30 mg; Drug: ADL5859 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00993863

33CL230

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

ADL5859 30 mg

Experimental group

Treatment:

Drug: ADL5859 30 mg

ADL5859 100 mg

Experimental group

Treatment:

Drug: ADL5859 100 mg

ADL5859 200 mg

Experimental group

Treatment:

Drug: ADL5859 200 mg

ibuprofen 400 mg

Active Comparator group

Treatment:

Drug: ibuprofen 400 mg