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

NCT03554772 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DFN-15-CD-010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

DFN-15 (Celecoxib Oral Solution) 62.5 mg

EXPERIMENTAL

Single dose containing 62.5 mg of celecoxib in 10 ml solution

Drug: DFN-15 (Celecoxib Oral Solution) 62.5 mg

DFN-15 (Celecoxib Oral Solution) 125 mg

EXPERIMENTAL

Single dose containing 125 mg of celecoxib in 10 ml solution

Drug: DFN-15 (Celecoxib Oral Solution) 125 mg

DFN-15 (Celecoxib Oral Solution) 250 mg

EXPERIMENTAL

Single dose containing 250 mg of celecoxib in 10 ml solution

Drug: DFN-15 (Celecoxib Oral Solution) 250 mg

Placebo

PLACEBO COMPARATOR

Single dose containing 0 mg of celecoxib in 10 ml solution

Drug: Placebo

Interventions

DFN-15 (Celecoxib Oral Solution) 62.5 mg DRUG

Oral Solution

DFN-15 (Celecoxib Oral Solution) 62.5 mg

DFN-15 (Celecoxib Oral Solution) 125 mg DRUG

Oral Solution

DFN-15 (Celecoxib Oral Solution) 125 mg

DFN-15 (Celecoxib Oral Solution) 250 mg DRUG

Oral Solution

DFN-15 (Celecoxib Oral Solution) 250 mg

Placebo DRUG

Oral Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia.
• 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.
• Subjects must voluntarily sign written informed consent prior to any study-specific procedures.
• Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than or equal to 35.0

You may not qualify if:

• History of migraine or frequent headaches, low back pain, or other acute or chronic pain conditions.
• Acute illness or unresolved local infection prior to surgery that can interfere with the conduct of the study.
• 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.
• Positive results for the following (prescription included): Amphetamines, Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and Tricyclic Antidepressants.
• Frequent use of nicotine-containing products.
• Excessive intake of caffeine-containing foods or beverages within 48 hours prior to surgery.
• Routinely uses pain medication.
• 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.
• 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.
• Donated blood products or had blood loss greater than 500 mL 30 days prior to Screening or between Screening and surgery.
• Member or relative of study staff or the Sponsor directly involved in the study.
• Previous participation in this study.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Site 101

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Singla N, Bertoch T, Shenoy S, Munjal S. Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study. Pain. 2022 Jan 1;163(1):91-99. doi: 10.1097/j.pain.0000000000002312.

  PMID: 34252915 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Srinivas Shenoy B.
• Organization: Dr Reddy's Laboratories, Inc.

srinivasshenoyb@drreddys.com

6099550249

Study Officials

• Elimor Brand-Schieber, PhD

  Director-Clinical Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 13, 2018
• Study Start: June 19, 2018
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)