Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

Pain Clinical Trial

Official title:

A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287350
• Other study ID #: 81-0074
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2014
• Last updated: March 9, 2016
• Start date: September 2014

Study information

• Verified date: March 2016
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

Description:

This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Male and female subjects between 2-12 years of age.

• Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

• Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.

• Subject has been taking analgesics for 48-72 hours prior to Screening.

• Subject has a history of any GI event greater than 6 months before Screening.

• Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.

• Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• diclofenac potassium oral solution
Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the PK profile of diclofenac potassium oral solution, with weight-based dosing, in pediatric subjects, ages 2-12 years experiencing mild to moderate acute pain.	PK parameters to be estimated are: Cmax; tmax; ?z: elimination rate constant associated with the terminal (log linear) portion of the curve; t1/2; AUC0 t: AUC from time of dose to last quantifiable sample collected before the second dose is given; AUC0 8: AUC from time of dosing (Time 0) extrapolated to infinity (8); CL/F: apparent clearance determined using Dose/AUC0 8; Vz/F: apparent volume of distribution calculated using apparent CLdivided by ?z	6 hours	No
Primary	To determine the safety and tolerability of diclofenac potassium in pediatric subjects, ages 2-12 years experiencing mild to moderate acute pain.	Safety Endpoints: Treatment emergent AEs (TEAEs); Serious adverse events (SAEs); Withdrawals due to AEs; Deaths; Observed values and changes in vital sign measurements; Observed values and changes in clinical laboratory results; Physical examination findings	up to 4 days of treatment	No