Pain, PostoperativePhase 2NCT02424578
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
A Phase 2 study testing Diclofenac Capsules low dose and Diclofenac Capsules high dose in people with Pain, Postoperative, run by Iroko Pharmaceuticals, LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Diclofenac Capsules low dose and Diclofenac Capsules high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2015to 19 Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Durham, North Carolina, 27705
Study site
Little Rock, Arkansas, 72202
Study site
Oklahoma City, Oklahoma, 73104
Study site
Philadelphia, Pennsylvania, 19104
Study site
Sheffield, Alabama, 35660
About this study
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
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.
- Conditions
- Pain, Postoperative
- Being tested
- Diclofenac Capsules low dose, Diclofenac Capsules high dose
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Capsules low doseDrug
Diclofenac Capsules high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Capsules low dose | Experimental | Diclofenac Capsules low dose three times daily for up to three days Receives: Drug: Diclofenac Capsules low dose |
| Diclofenac Capsules high dose | Experimental | Diclofenac Capsules high dose three times daily for up to three days Receives: Drug: Diclofenac Capsules high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-6 hours after first dose of diclofenac
Secondary outcomes (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
Measured: Baseline to Day 3/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completion19 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424578
- Sponsor's protocol ID
- DIC2-14-08
- Status last verified
- Jun 2017
- First submitted
- 20 Apr 2015
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02424578
- Acronym / sponsor ID
- DIC2-14-08
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- 19 Apr 2016 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Capsules low dose | Experimental | Drug: Diclofenac Capsules low doseDiclofenac Capsules low dose three times daily for up to three days |
| Diclofenac Capsules high dose | Experimental | Drug: Diclofenac Capsules high doseDiclofenac Capsules high dose three times daily for up to three days |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac Capsules low dose | Drug | Diclofenac Capsules low dose |
| Diclofenac Capsules high dose | Drug | Diclofenac Capsules high dose |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diclofenac Capsules low dose and Diclofenac Capsules high dose in people with Pain, Postoperative, run by Iroko Pharmaceuticals, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Diclofenac (time frame: 0-6 hours after first dose of diclofenac). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.