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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424578
• Other study ID #: DIC2-14-08
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2015
• Last updated: April 25, 2016
• Start date: May 2015

Study information

• Verified date: April 2016
• Source: Iroko Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Diclofenac Capsules low dose

• Diclofenac Capsules high dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iroko Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of diclofenac		0-6 hours after first dose of diclofenac	No
Secondary	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	Yes