Status:
COMPLETED
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Lead Sponsor:
Depomed
Conditions:
Pain
Eligibility:
All Genders
2-12 years
Phase:
PHASE4
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 diclofe...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02287350
Start Date
September 1 2014
End Date
January 1 2016
Last Update
July 11 2017
Active Locations (5)
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1
Sheffield, Alabama, United States
2
Stanford, California, United States
3
City of Saint Peters, Missouri, United States
4
Dallas, Texas, United States