Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15

• Status: Completed
• Trial end date: 2018-08-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Celecoxib; Pharmaceutical Solutions

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.