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

NCT02633969 | Completed Phase 2

• 1 other identifier: IND2-15-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of indomethacin

  The estimated typical value for clearance (tvCL) following a single indomethacin dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.

  0-12 hours after first dose of indomethacin

Secondary Outcomes (1)

• Safety of Indomethacin Capsules low dose and high dose as assessed by the incidence of adverse events from baseline to Day 3 or early termination

  Baseline to Day 3/Early Termination

Study Arms (2)

Indomethacin Capsules low dose

EXPERIMENTAL

Indomethacin Capsules low dose twice daily for up to three days

Drug: Indomethacin Capsules low dose

Indomethacin Capsules high dose

EXPERIMENTAL

Indomethacin Capsules high dose twice daily for up to three days

Drug: Indomethacin Capsules high dose

Interventions

Indomethacin Capsules low dose DRUG

Indomethacin Capsules low dose

Indomethacin Capsules high dose DRUG

Indomethacin Capsules high dose

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Body weight ≥20 kilograms
• Mild to moderate acute pain requiring treatment with analgesic medication
• Willing to have blood samples taken for PK sampling using an indwelling catheter
• Must be able to swallow capsules and can tolerate oral medication
• For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control

You may not qualify if:

• Severe acute pain
• Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug
• Emergency surgery
• History of allergic reaction, hypersensitivity, or clinically significant intolerance to indomethacin, aspirin, codeine, acetaminophen, or any NSAID
• History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
• Current use of any medication that may cause a clinically significant drug interaction when co-administered with indomethacin
• Current use of any medication that might affect the pharmacokinetics of indomethacin
• History of bleeding disorders
• Developmental delay or behavioral problems that would make it difficult to assess pain
• Impaired liver function
• Clinically significant renal or cardiovascular disease
• Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
• Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study
• Previous participation in this clinical study or currently taking indomethacin

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC: lead

Study Sites (5)

Unknown Facility

Sheffield, Alabama, 35660, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Coral Gables, Florida, 33146, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Unknown Facility

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (5)