Ibuprofen Extended-Release Dental Pain Study

Inclusion Criteria:

• Males and females 16 to 45 years of age;

• Outpatients scheduled to undergo surgical extraction of 1-2 impacted third molar(s),one of which must be a mandibular impaction that is partially impacted in eithertissue or bone;

• At least a score of 5 on the 11-point pain intensity numerical rating scale (PI-NRS)at baseline;

• Use of only the following preoperative medication(s) / anesthetic(s): short-actinglocal anesthetic (e.g., mepivacaine or lidocaine) with or without vasoconstrictorand/or nitrous oxide;

• Reliable, cooperative, and adequate intelligence to record the requested informationon the analgesic questionnaire form;

• Subjects (or the parent or legal guardian of subjects under the age of 18 years) arerequired to read, comprehend, and sign the informed consent. Subjects requiring aparent or legal guardian to sign the informed consent will be required to sign anassent;

• Examined by the attending dentist or physician and medically cleared to participate inthe study; and,

• In general good health and have no contraindications to any of the study meds.

Exclusion Criteria:

• Presence of a serious medical condition (e.g., poorly controlled hypertension, poorlycontrolled diabetes, significantly impaired cardiac, renal or hepatic function, hyper-or hypothyroidism);

• Use of a prescription or nonprescription drug with which the administration ofibuprofen, celecoxib, any other non-steroidal anti-inflammatory drug (NSAID), oracetaminophen, is contraindicated;

• Acute local infection at the time of surgery that could confound the post-surgicalevaluation;

• Females who are pregnant, lactating, of child-bearing potential, or postmenopausal forless than 2 years and not using a medically approved method of contraception (i.e.,oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm,condom, abstinence, or surgical sterility), or females who test positive on aurine-based pregnancy test;

• Presence or history (within 2 years of enrollment) of bleeding disorder(s) or pepticulcer disease;

• Presence or history (within the past year) of alcoholism or substance abuse. Subjectswho are taking CNS or other psychotropic drugs (including St. John's Wort, or anyother nutritional supplement known to have psychotropic effects) may be enrolled ifthey have been on stable doses of medication for at least 2 months, will maintain thisdose throughout the study, and their condition is judged by the Principal Investigatorto be well-controlled;

• Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more timesper week);

• History of allergic reaction (eg, asthma, rhinitis, swelling, shock, or hives) toibuprofen, naproxen, aspirin, celecoxib, any other NSAID, or acetaminophen;

• Prior use of any type of analgesic or NSAID 5 half-lives of that drug or less beforetaking the first dose of study medication, except for pre-anesthetic medication andanesthesia for the procedure;

• Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or lessbefore taking the first dose of study medication;

• Has taken an investigational product within the past 30 days;

• Has previously been entered into this study; and,

• The subject is a member of the study site staff either directly involved with thestudy, an employee of the Sponsor, or a relative of study site personnel directlyinvolved with the study or Sponsor.