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

NCT ID: NCT02424578

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-04-19

Brief Summary

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diclofenac Capsules low dose

Diclofenac Capsules low dose three times daily for up to three days

Group Type: EXPERIMENTAL

Diclofenac Capsules low dose

Intervention Type: DRUG

Diclofenac Capsules high dose

Diclofenac Capsules high dose three times daily for up to three days

Group Type: EXPERIMENTAL

Diclofenac Capsules high dose

Intervention Type: DRUG

Interventions

Diclofenac Capsules low dose

Intervention Type: DRUG

Diclofenac Capsules high dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iroko Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheffield, Alabama, United States

Little Rock, Arkansas, United States

Durham, North Carolina, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

DIC2-14-08

Identifier Type: -

Identifier Source: org_study_id