--- title: Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain nct_id: NCT02287350 overall_status: COMPLETED phase: PHASE4 sponsor: Depomed study_type: INTERVENTIONAL primary_condition: Pain countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02287350.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02287350" ct_last_update_post_date: 2017-07-11 last_seen_at: "2026-05-12T06:04:28.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain **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 ID:** [NCT02287350](https://clinicaltrials.gov/study/NCT02287350) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 51 - **Lead Sponsor:** Depomed - **Conditions:** Pain - **Start Date:** 2014-09 - **Completion Date:** 2016-01 - **CT.gov Last Update:** 2017-07-11 ## 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. ## Eligibility - **Minimum age:** 2 Years - **Maximum age:** 12 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **diclofenac potassium oral solution** (EXPERIMENTAL) — 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. ## Interventions - **diclofenac potassium oral solution** (DRUG) — Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain. ## Primary Outcomes - **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).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • Cmax: maximum concentration (ng/mL) - **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).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • Tmax: time to maximum concentration (hr) - **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 (3 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • λz: elimination rate constant (1/hr) - **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 (4 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • t1/2: terminal elimination half-life (hr) - **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 (5 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr\*ng/mL) - **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 (6 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\*ng/mL) - **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 (7 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • CL/F: apparent clearance (mL/hr). - **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 (8 of 8).** _(time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose))_ — • Vz/F: apparent volume of distribution (mL). ## Secondary Outcomes - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).** _(time frame: 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).** _(time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).** _(time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).** _(time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ - **To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).** _(time frame: 4 weeks (signed informed consent/assent to the final visit))_ ## Locations (5) - Sheffield, Alabama, United States - Stanford, California, United States - City of Saint Peters, Missouri, United States - Dallas, Texas, United States - Milwaukee, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|sheffield|alabama|united states` — added _(2026-05-12)_ - `locations.|stanford|california|united states` — added _(2026-05-12)_ - `locations.|city of saint peters|missouri|united states` — added _(2026-05-12)_ - `locations.|dallas|texas|united states` — added _(2026-05-12)_ - `locations.|milwaukee|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02287350.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02287350* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*