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Study of Diclofenac 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: NCT02424578
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
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 diclofenac 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: Diclofenac Capsules low dose Drug: Diclofenac Capsules high dose Phase 2

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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 Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 19, 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Plasma Concentration of Diclofenac [ Time Frame: 0-6 hours after first dose of diclofenac ]
    The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.

Secondary Outcome Measures :
  1. Safety of Diclofenac 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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Body weight ≥18 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 diclofenac, 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 diclofenac
  • Current use of any medication that might affect the pharmacokinetics of diclofenac
  • 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 diclofenac.

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): NCT02424578

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United States, Alabama
Sheffield, Alabama, United States, 35660
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC

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Responsible Party: Iroko Pharmaceuticals, LLC Identifier: NCT02424578     History of Changes
Other Study ID Numbers: DIC2-14-08
First Posted: April 23, 2015    Key Record Dates
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action