PainPhase 4NCT02287350
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
A Phase 4 study testing diclofenac potassium oral solution in people with Pain, run by Depomed at 5 sites in United States.
Trial summary
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain
- What is being tested?
- diclofenac potassium oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 4
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects between 2-12 years of age.
- Subjects must be post-op, having mild or moderate acute pain.
- Other inclusions apply.
Who cannot join
- Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
- Subject has been taking analgesics for 48-72 hours prior to Screening.
- Subject has a history of any GI event greater than 6 months before Screening.
- Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
- Subject is requiring treatment for pre-existing hypertension.
- Other exclusions apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
City of Saint Peters, Missouri
Study site
Dallas, Texas
Study site
Milwaukee, Wisconsin
Study site
Sheffield, Alabama
Study site
Stanford, California
About this study
Official title: A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.
Read the detailed description
This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.
- Conditions
- Pain
- Being tested
- diclofenac potassium oral solution
- Keywords
- pain, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain, NSAID, nonsteroidal anti-inflammatory drug
- Medical subject headings
- Pain, Acute Pain, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac potassium oral solutionDrug
Also called diclofenac
Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
| Study group | Role | What they receive |
|---|---|---|
| diclofenac potassium oral solution | Experimental | 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. Receives: Drug: diclofenac potassium oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
- Cmax: maximum concentration (ng/mL)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).
- Tmax: time to maximum concentration (hr)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).
- λz: elimination rate constant (1/hr)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).
- t1/2: terminal elimination half-life (hr)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).
- AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).
- AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).
- CL/F: apparent clearance (mL/hr).
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).
- Vz/F: apparent volume of distribution (mL).
Measured: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Secondary outcomes (34)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).
- Treatment emergent AEs (TEAEs)
Measured: 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).
- Serious adverse events (SAEs)
Measured: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).
- Withdrawals due to AEs
Measured: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).
- Deaths
Measured: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).
- Changes in vital sign measurements: Temperature (degrees C).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).
- Changes in vital sign measurements: Pulse Rate (beats/min).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).
- Changes in vital sign measurements: Respiratory Rate (breaths/min).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).
- Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).
- Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).
- Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).
- Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).
- Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).
- Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).
- Changes in clinical laboratory results: Hematology - Basophils (%).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).
- Changes in clinical laboratory results: Hematology - Eosinophils (%).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).
- Changes in clinical laboratory results: Hematology - Neutrophils (%).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).
- Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).
- Changes in clinical laboratory results: Hematology - Monocytes (%).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).
- Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).
- Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).
- Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).
- Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).
- Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).
- Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).
- Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).
- Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).
- Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).
- Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).
- Changes in clinical laboratory results: Chemistry - LDH (U/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).
- Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).
- Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).
- Changes in clinical laboratory results: Urinalysis - pH.
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).
- Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Measured: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).
- Physical examination findings including abnormal clinically significant findings
Measured: 4 weeks (signed informed consent/assent to the final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 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 PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Depomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287350
- Sponsor's protocol ID
- 81-0074
- Status last verified
- Jun 2017
- First submitted
- 27 Oct 2014
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain
- ClinicalTrials.gov ID
- NCT02287350
- Acronym / sponsor ID
- 81-0074
- Conditions
- Pain
- Keywords
- pain, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain, NSAID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- DepomedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.
Detailed description
This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diclofenac potassium oral solution | Experimental | Drug: diclofenac potassium oral solution5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female subjects between 2-12 years of age.
- Subjects must be post-op, having mild or moderate acute pain.
- Other inclusions apply.
Key exclusion criteria (6 listed)
- Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
- Subject has been taking analgesics for 48-72 hours prior to Screening.
- Subject has a history of any GI event greater than 6 months before Screening.
- Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
- Subject is requiring treatment for pre-existing hypertension.
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 potassium oral solutionAlso: diclofenacAdministration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain. | Drug | diclofenac potassium oral solution |
Primary outcome
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• Cmax: maximum concentration (ng/mL)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• Tmax: time to maximum concentration (hr)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• λz: elimination rate constant (1/hr)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• t1/2: terminal elimination half-life (hr)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• CL/F: apparent clearance (mL/hr).
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).
Time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
• Vz/F: apparent volume of distribution (mL).
34 secondary outcomes
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).
Time frame: 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).
Time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).
Time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).
Time frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).
Time frame: 4 weeks (signed informed consent/assent to the final visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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 4 study testing diclofenac potassium oral solution in people with Pain, run by Depomed 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 3 inclusion and 6 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 11 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 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?
To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8). (time frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)). The study lists 8 primary outcomes in all. 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 11 Jul 2017.