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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993863
• Other study ID #: 33CL230
• Secondary ID: 33CL230
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2009
• Last updated: July 16, 2015
• Start date: June 2007

Study information

• Verified date: October 2009
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Placebo
single dose
• ADL5859 30 mg
single dose
• ADL5859 100 mg
single dose
• ADL5859 200 mg
single dose
• ibuprofen 400 mg
single dose

Locations

Country	Name	City	State
United States	SCIREX Research Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pain relief 0-4 hours after study medication		4 hours after study medication	No