Acute Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, Safety and Pharmacokinetic Study of Single Doses of DFN-15 in Post-Surgical Dental Pain
Verified date | August 2020 |
Source | Dr. Reddy's Laboratories Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental Pain.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 20, 2018 |
Est. primary completion date | August 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Site 101 | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Dr. Reddy's Laboratories Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Summed Pain Intensity Difference Over the First Six Hours | The primary endpoint is the Summed Pain Intensity Difference over the first 6 hours (SPID6) after dosing compared between DFN-15 and placebo. Pain intensity (P) will be measured at timepoints of 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5 and 6, hours after baseline ,using 11-point Pain Intensity Numerical Rating Scale (NPRS). Zero (0) equals no pain and Ten (10) equals worst pain imaginable. SPID6 is created by summing the time weighted pain intensity differences (PID) scores using the area under the PID curve methodology. All SPID calculations will be performed using the standard trapezoidal rule SPIDx =?_(i=0)^x¦((?PID?_i+?PID?_(i+1))/2) * (T_(i+1)- T_i ) Where: PID_i = P_i - PBL (Pain score at time i and Pain score at Baseline), and (T_i+1 - T_i) is the Time difference in minutes between time i and time i+1. Therefore, SPID6 values may theoretically range between a maximum score of 0 ( no improvement) and a minimum score of -3525 (best improvement) |
6 hours post dose |
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