Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: DFN-15 (Celecoxib Oral Solution) 62.5 mg; DFN-15 (Celecoxib Oral Solution) 125 mg; DFN-15 (Celecoxib Oral Solution) 250 mg; Placebo
Intervention description: Oral Solution; Oral Solution; Oral Solution; Oral Solution
Intervention MeSH terms: Celecoxib; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental
      Pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects scheduled to undergo elective bilateral lower (mandibular) third molar
             extraction under local anesthesia.

          2. Subjects must be generally healthy, ambulatory, able to understand and willing to
             comply with study procedures, study restrictions, assessments, and requirements per
             the discretion of the investigator.

          3. Subjects must voluntarily sign written informed consent prior to any study-specific
             procedures.

          4. Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than
             or equal to 35.0

        Exclusion Criteria:

          1. History of migraine or frequent headaches, low back pain, or other acute or chronic
             pain conditions.

          2. Acute illness or unresolved local infection prior to surgery that can interfere with
             the conduct of the study.

          3. Positive results on urine drug screen or alcohol breath test indicative of illicit
             drug (Cocaine Metabolites, Marijuana (THC), MDMA (Ecstasy) and Phencyclidine) or
             alcohol abuse at screening and/or prior to extraction procedure.

          4. Positive results for the following (prescription included): Amphetamines,
             Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and
             Tricyclic Antidepressants.

          5. Frequent use of nicotine-containing products.

          6. Excessive intake of caffeine-containing foods or beverages within 48 hours prior to
             surgery.

          7. Routinely uses pain medication.

          8. Currently taking any corticosteroid chronically (except for an inhaled steroid for
             pulmonary disease, and local topical or ophthalmic steroid) or has taken systemic
             corticosteroids within 4 weeks of the proposed date of surgery.

          9. Currently taking central nervous system active drugs such as hypnotics, sedatives,
             monoamine oxidase inhibitors, sympathomimetic amines, benzodiazepines, tricyclic
             antidepressants, or serotonin norepinephrine reuptake inhibitors, and anticonvulsants
             for pain.

         10. Donated blood products or had blood loss greater than 500 mL 30 days prior to
             Screening or between Screening and surgery.

         11. Member or relative of study staff or the Sponsor directly involved in the study.

         12. Previous participation in this study.

         13. Has received another new chemical entity (defined as a compound which has not been
             approved for marketing) or has participated in any other clinical study that included
             drug treatment within 30 days prior to the Screening visit.

         14. Currently receiving or have received within 7 days prior to investigational product
             administration in the study, any drug (s) that is metabolized by hepatic microsomal
             enzyme CYP 2D6.

         15. Clinically significant disease or disorder which may put the subject at risk,
             influence the results or the subject's ability to participate in the study.