Trial Outcomes & Findings for Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age (NCT NCT02424578)
NCT ID: NCT02424578
Last Updated: 2017-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
0-6 hours after first dose of diclofenac
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Diclofenac Capsules Low Dose
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Diclofenac Capsules Low Dose
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Baseline characteristics by cohort
| Measure |
Diclofenac Capsules Low Dose
n=15 Participants
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
n=15 Participants
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.0 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 1.51 • n=7 Participants
|
11.6 years
STANDARD_DEVIATION 3.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Weight
|
40.20 kg
STANDARD_DEVIATION 16.628 • n=5 Participants
|
74.44 kg
STANDARD_DEVIATION 18.974 • n=7 Participants
|
57.34 kg
STANDARD_DEVIATION 24.693 • n=5 Participants
|
|
Weight Group
>/=18 to <35 kg
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Weight Group
>/=35 kg
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-6 hours after first dose of diclofenacPopulation: 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.
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.
Outcome measures
| Measure |
Diclofenac Capsules Low Dose
n=15 Participants
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
n=15 Participants
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
|---|---|---|
|
Plasma Concentration of Diclofenac
|
29647.9 mL/hr
Standard Error 3710.526
|
35131.0 mL/hr
Standard Error 5660.83
|
SECONDARY outcome
Timeframe: Baseline to Day 3/Early TerminationOutcome measures
Outcome data not reported
Adverse Events
Diclofenac Capsules Low Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Diclofenac Capsules High Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diclofenac Capsules Low Dose
n=15 participants at risk
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
n=15 participants at risk
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
|---|---|---|
|
Infections and infestations
Postoperative abcess
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
0.00%
0/15 • 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).
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.
|
Other adverse events
| Measure |
Diclofenac Capsules Low Dose
n=15 participants at risk
Diclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules low dose
|
Diclofenac Capsules High Dose
n=15 participants at risk
Diclofenac Capsules high dose three times daily for up to three days
Diclofenac Capsules high dose
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 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).
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.
|
20.0%
3/15 • Number of events 3 • 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).
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.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 3 • 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).
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.
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • 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).
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.
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
0.00%
0/15 • 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).
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
0.00%
0/15 • 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).
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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
0.00%
0/15 • 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).
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.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
0.00%
0/15 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/15 • 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).
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.
|
6.7%
1/15 • Number of events 1 • 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).
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.
|
Additional Information
SVP Medical Affairs, Pharmacovigilance and Medical Information
Iroko Pharmaceuticals
Phone: 2675463003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60