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
NCT number | NCT02287350 |
Other study ID # | 81-0074 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | October 27, 2014 |
Last updated | March 9, 2016 |
Start date | September 2014 |
Verified date | March 2016 |
Source | Depomed |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Depomed |
United States,
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 |
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