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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Capsules low dose
Diclofenac Capsules high dose
Sponsored by
Iroko Pharmaceuticals, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diclofenac Capsules low dose

Diclofenac Capsules high dose

Arm Description

Diclofenac Capsules low dose three times daily for up to three days

Diclofenac Capsules high dose three times daily for up to three days

Outcomes

Primary Outcome Measures

Plasma Concentration 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

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

Full Information

First Posted
April 20, 2015
Last Updated
June 14, 2017
Sponsor
Iroko Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02424578
Brief Title
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
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 Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iroko Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Capsules low dose
Arm Type
Experimental
Arm Description
Diclofenac Capsules low dose three times daily for up to three days
Arm Title
Diclofenac Capsules high dose
Arm Type
Experimental
Arm Description
Diclofenac Capsules high dose three times daily for up to three days
Intervention Type
Drug
Intervention Name(s)
Diclofenac Capsules low dose
Intervention Type
Drug
Intervention Name(s)
Diclofenac Capsules high dose
Primary Outcome Measure Information:
Title
Plasma Concentration of Diclofenac
Description
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.
Time Frame
0-6 hours after first dose of diclofenac
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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