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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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ClinicalTrials.gov Identifier: NCT02424578
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Diclofenac Capsules low dose
Drug: Diclofenac Capsules high dose
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Hide Arm/Group Description

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

Diclofenac Capsules low dose

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

Diclofenac Capsules high dose

Period Title: Overall Study
Started 15 15
Completed 15 14
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Diclofenac Capsules Low Dose Diclofenac Capsules High Dose Total
Hide Arm/Group Description

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

Diclofenac Capsules low dose

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

Diclofenac Capsules high dose

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
Safety Population (all subjects receiving at least one dose of study medication)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
15
 100.0%
15
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
9.0  (1.69) 14.1  (1.51) 11.6  (3.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
11
  73.3%
6
  40.0%
17
  56.7%
Male
4
  26.7%
9
  60.0%
13
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
15
 100.0%
30
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  33.3%
2
  13.3%
7
  23.3%
White
9
  60.0%
11
  73.3%
20
  66.7%
More than one race
0
   0.0%
1
   6.7%
1
   3.3%
Unknown or Not Reported
1
   6.7%
1
   6.7%
2
   6.7%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 15 participants 15 participants 30 participants
40.20  (16.628) 74.44  (18.974) 57.34  (24.693)
Weight Group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
>/=18 to <35 kg
7
  46.7%
0
   0.0%
7
  23.3%
>/=35 kg
8
  53.3%
15
 100.0%
23
  76.7%
1.Primary Outcome
Title Plasma Concentration of Diclofenac
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population. Defined as all subjects who received at least one dose of study drug and had at least one quantifiable plasma diclofenac concentration after dosing.
Arm/Group Title Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Hide Arm/Group Description:

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

Diclofenac Capsules low dose

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

Diclofenac Capsules high dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: mL/hr
29647.9  (3710.526) 35131.0  (5660.83)
2.Secondary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline to Day 3/Early Termination
Outcome Measure Data Not Reported
Time Frame Adverse Events (AEs) were collected from the signing of the informed consent document, through the study follow up visit (approximately 1 week after the final dose of diclofenac).
Adverse Event Reporting Description Standard AE definitions were used. AE data were collected using non-leading questioning for subjects who were inpatients, and were collected using a take-home signs and symptoms diary (with parent/guardian assistance) for outpatient subjects. Daily phone calls were made to outpatient subjects to ensure compliance with diary collection procedures.
 
Arm/Group Title Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Hide Arm/Group Description

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

Diclofenac Capsules low dose

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

Diclofenac Capsules high dose

All-Cause Mortality
Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)    
Infections and infestations     
Postoperative abcess  1  1/15 (6.67%)  1 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diclofenac Capsules Low Dose Diclofenac Capsules High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/15 (46.67%)      7/15 (46.67%)    
Gastrointestinal disorders     
Nausea  1  0/15 (0.00%)  0 3/15 (20.00%)  3
Vomiting  1  2/15 (13.33%)  3 1/15 (6.67%)  1
Abdominal pain  1  0/15 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Pain  1  1/15 (6.67%)  1 0/15 (0.00%)  0
Pyrexia  1  1/15 (6.67%)  1 0/15 (0.00%)  0
Infections and infestations     
Pharyngitis streptococcal  1  1/15 (6.67%)  1 0/15 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural pain  1  1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/15 (6.67%)  1 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/15 (6.67%)  1 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Rash pruritic  1  0/15 (0.00%)  0 1/15 (6.67%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SVP Medical Affairs, Pharmacovigilance and Medical Information
Organization: Iroko Pharmaceuticals
Phone: 2675463003 ext 3182
EMail: eoimagosie@iroko.com
Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02424578     History of Changes
Other Study ID Numbers: DIC2-14-08
First Submitted: April 20, 2015
First Posted: April 23, 2015
Results First Submitted: June 14, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017