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

NCT02287350 | Completed Phase 4 Results

• 1 other identifier: 81-0074
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain

Keywords

pain; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain; NSAID; nonsteroidal anti-inflammatory drug

Outcome Measures

Primary Outcomes (8)

• 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).

  • Cmax: maximum concentration (ng/mL)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • Tmax: time to maximum concentration (hr)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • λz: elimination rate constant (1/hr)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • t1/2: terminal elimination half-life (hr)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • 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)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\*ng/mL)

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • CL/F: apparent clearance (mL/hr).

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

• 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).

  • Vz/F: apparent volume of distribution (mL).

  6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)

Secondary Outcomes (34)

• 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).

  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).

  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).

  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).

  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).

  4 weeks (signed informed consent/assent to the final visit)

Study Arms (1)

diclofenac potassium oral solution

EXPERIMENTAL

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

Drug: diclofenac potassium oral solution

Interventions

diclofenac potassium oral solution DRUG

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

Also known as: diclofenac

diclofenac potassium oral solution

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects between 2-12 years of age.
• Subjects must be post-op, having mild or moderate acute pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Depomed: lead

Study Sites (5)

Unknown Facility

Sheffield, Alabama, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

City of Saint Peters, Missouri, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain; Lymphoma, Follicular

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Clinical Operations
• Organization: Depomed

clinicaltrials@depomed.com

510-744-8000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 10, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (5)