Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT02287350
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Sponsor:
Depomed
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: