Ibuprofen Extended-Release Dental Pain Study
Condition: Pain; Post-Operative Pain; Third Molar Extraction
MeSH terms: Pain, Postoperative
Intervention: Ibuprofen 600 mg Extended-Release Tablets; Placebo
Intervention description: Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.; Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the efficacy and safety of multiple doses of
      Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of
      third molar teeth.
    

Eligibility criteria:

        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 either
             tissue 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-acting
             local anesthetic (e.g., mepivacaine or lidocaine) with or without vasoconstrictor
             and/or nitrous oxide;

          -  Reliable, cooperative, and adequate intelligence to record the requested information
             on the analgesic questionnaire form;

          -  Subjects (or the parent or legal guardian of subjects under the age of 18 years) are
             required to read, comprehend, and sign the informed consent. Subjects requiring a
             parent or legal guardian to sign the informed consent will be required to sign an
             assent;

          -  Examined by the attending dentist or physician and medically cleared to participate in
             the 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, poorly
             controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper-
             or hypothyroidism);

          -  Use of a prescription or nonprescription drug with which the administration of
             ibuprofen, celecoxib, any other non-steroidal anti-inflammatory drug (NSAID), or
             acetaminophen, is contraindicated;

          -  Acute local infection at the time of surgery that could confound the post-surgical
             evaluation;

          -  Females who are pregnant, lactating, of child-bearing potential, or postmenopausal for
             less 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 a
             urine-based pregnancy test;

          -  Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic
             ulcer disease;

          -  Presence or history (within the past year) of alcoholism or substance abuse. Subjects
             who are taking CNS or other psychotropic drugs (including St. John's Wort, or any
             other nutritional supplement known to have psychotropic effects) may be enrolled if
             they have been on stable doses of medication for at least 2 months, will maintain this
             dose throughout the study, and their condition is judged by the Principal Investigator
             to be well-controlled;

          -  Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times
             per week);

          -  History of allergic reaction (eg, asthma, rhinitis, swelling, shock, or hives) to
             ibuprofen, 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 before
             taking the first dose of study medication, except for pre-anesthetic medication and
             anesthesia for the procedure;

          -  Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less
             before 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 the
             study, an employee of the Sponsor, or a relative of study site personnel directly
             involved with the study or Sponsor.