Clinical trial · Interventional
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
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
NCT02287350CI-TRIAL-00028534completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diclofenac potassium oral solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- diclofenac potassium oral solution
- description
- 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
- interventionNames
- Drug: diclofenac potassium oral solution
Primary outcomes (8)
- measure
- To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
- timeFrame
- 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
- description
- • Cmax: maximum concentration (ng/mL)
- measure
- To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.