Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02633969
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : January 26, 2018
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Indomethacin Capsules low dose Drug: Indomethacin Capsules high dose Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIA, Open-label, Safety and Pharmacokinetic Study of Indomethacin Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery
Study Start Date : December 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Indomethacin Capsules low dose
Indomethacin Capsules low dose twice daily for up to three days
Drug: Indomethacin Capsules low dose
Experimental: Indomethacin Capsules high dose
Indomethacin Capsules high dose twice daily for up to three days
Drug: Indomethacin Capsules high dose

Primary Outcome Measures :
  1. Plasma Concentrations of indomethacin [ Time Frame: 0-12 hours after first dose 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.

Secondary Outcome Measures :
  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 [ Time Frame: Baseline to Day 3/Early Termination ]

    Tivorbex Capsules 20 mg and 40 mg were generally well tolerated. No deaths or SAEs were reported. Overall, 6 subjects (20.0%) experienced at least 1 TEAE during the study. All TEAEs were mild in intensity and 2 TEAEs (1 in each treatment group) of vomiting were considered to be related to the study drug.

    The most common TEAEs were vomiting (13.3%) and nausea (6.7%). Vomiting and nausea were the only TEAEs reported in >1 subject in either group. The frequency of nausea and vomiting observed in this study is consistent with the findings from previous pediatric studies on NSAIDs.No gastrointestinal AEs commonly reported with NSAIDs, such as bleeding, ulceration, or perforation of the stomach and intestines were reported, nor were cardiovascular thrombotic events.No AEs of acute-type allergic reaction or bronchospasm were reported.

    Vital sign and physical examination findings did not reveal any safety concerns; specifically no new onset hypertension was observed during the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02633969

Layout table for location information
United States, Alabama
Sheffield, Alabama, United States, 35660
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Coral Gables, Florida, United States, 33146
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Utah
Orem, Utah, United States, 84058
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC

Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC Identifier: NCT02633969     History of Changes
Other Study ID Numbers: IND2-15-08
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Tocolytic Agents
Reproductive Control Agents
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action