Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Plasma Concentration of Diclofenac [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
- 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 [Baseline to Day 3/Early Termination]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheffield | Alabama | United States | 35660 | |
| 2 | Little Rock | Arkansas | United States | 72202 | |
| 3 | Durham | North Carolina | United States | 27705 | |
| 4 | Oklahoma City | Oklahoma | United States | 73104 | |
| 5 | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Iroko Pharmaceuticals, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIC2-14-08
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Diclofenac Capsules Low Dose | Diclofenac Capsules High Dose |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Diclofenac Capsules Low Dose | Diclofenac Capsules High Dose | Total |
|---|---|---|---|
| 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 Participants | 15 | 15 | 30 |
| Age (Count of Participants) | |||
| <=18 years |
15
100%
|
15
100%
|
30
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.0
(1.69)
|
14.1
(1.51)
|
11.6
(3.05)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
11
73.3%
|
6
40%
|
17
56.7%
|
| Male |
4
26.7%
|
9
60%
|
13
43.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
15
100%
|
15
100%
|
30
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
33.3%
|
2
13.3%
|
7
23.3%
|
| White |
9
60%
|
11
73.3%
|
20
66.7%
|
| More than one race |
0
0%
|
1
6.7%
|
1
3.3%
|
| Unknown or Not Reported |
1
6.7%
|
1
6.7%
|
2
6.7%
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
40.20
(16.628)
|
74.44
(18.974)
|
57.34
(24.693)
|
| Weight Group (Count of Participants) | |||
| >/=18 to <35 kg |
7
46.7%
|
0
0%
|
7
23.3%
|
| >/=35 kg |
8
53.3%
|
15
100%
|
23
76.7%
|
Outcome Measures
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 15 | 15 |
| Mean (Standard Error) [mL/hr] |
29647.9
(3710.526)
|
35131.0
(5660.83)
|
| 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 |
|---|---|
| Description | |
| Time Frame | Baseline to Day 3/Early Termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| Diclofenac Capsules Low Dose | Diclofenac Capsules High Dose | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/15 (6.7%) | 0/15 (0%) | ||
| Infections and infestations | ||||
| Postoperative abcess | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Diclofenac Capsules Low Dose | Diclofenac Capsules High Dose | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/15 (46.7%) | 7/15 (46.7%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 0/15 (0%) | 0 | 3/15 (20%) | 3 |
| Vomiting | 2/15 (13.3%) | 3 | 1/15 (6.7%) | 1 |
| Abdominal pain | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| General disorders | ||||
| Pain | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Pyrexia | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Infections and infestations | ||||
| Pharyngitis streptococcal | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Procedural pain | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Nervous system disorders | ||||
| Dizziness | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Oropharyngeal pain | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Rash pruritic | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | SVP Medical Affairs, Pharmacovigilance and Medical Information |
|---|---|
| Organization | Iroko Pharmaceuticals |
| Phone | 2675463003 ext 3182 |
| eoimagosie@iroko.com |
- DIC2-14-08