Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

NCT01378988

Sedation Pain

COMPLETED PHASE2

Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age

NCT02424578

Pain, Postoperative

COMPLETED PHASE2

Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

NCT01257126

Upper Respiratory Tract Infections

WITHDRAWN PHASE4

Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

NCT05315479

Post Operative Pain

TERMINATED PHASE4

Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

NCT03485014

Postoperative Pain Management

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diclofenac potassium oral solution

5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.

Group Type EXPERIMENTAL

diclofenac potassium oral solution

Intervention Type DRUG

Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diclofenac potassium oral solution

Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

diclofenac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No