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

NCT03554772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-22

Study results available
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Summary

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

Conditions

  • Acute Pain

Interventions

DRUG

DFN-15 (Celecoxib Oral Solution) 62.5 mg

Oral Solution

DRUG

DFN-15 (Celecoxib Oral Solution) 125 mg

Oral Solution

DRUG

DFN-15 (Celecoxib Oral Solution) 250 mg

Oral Solution

DRUG

Placebo

Oral Solution

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Elimor Brand-Schieber, PhD · Director-Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2018-08-20
Completion
2018-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554772 on ClinicalTrials.gov