Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age

A Phase IIA, Open-Label, Safety and Pharmacokinetic Study of Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Diclofenac Capsules low dose; Drug: Diclofenac Capsules high dose

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
  • North Carolina
    • Durham, North Carolina, United States, 27705
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body weight ≥18 kilograms.
• Mild to moderate acute pain requiring treatment with analgesic medication.
• Willing to have blood samples taken for PK sampling using an indwelling catheter.
• Must be able to swallow capsules and can tolerate oral medication.
• For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control

Exclusion Criteria:

• Severe acute pain
• Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug.
• Emergency surgery
• History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID
• History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
• Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac
• Current use of any medication that might affect the pharmacokinetics of diclofenac
• History of bleeding disorders .
• Developmental delay or behavioral problems that would make it difficult to assess pain.
• Impaired liver function
• Clinically significant renal or cardiovascular disease
• Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
• Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study.
• Previous participation in this clinical study or currently taking diclofenac.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Capsules low dose; Diclofenac Capsules low dose three times daily for up to three days	Drug: Diclofenac Capsules low dose
Experimental: Diclofenac Capsules high dose; Diclofenac Capsules high dose three times daily for up to three days	Drug: Diclofenac Capsules high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Diclofenac	The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.	0-6 hours after first dose of diclofenac

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination	Baseline to Day 3/Early Termination

Collaborators and Investigators

• Sponsor: Iroko Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 19, 2016

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: DIC2-14-08