Pain
Conditions
Keywords
pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain
Brief summary
As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
Detailed description
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.
Interventions
DRUGZipsor®
Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.
Sponsors
Depomed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects between 12-17 years of age. * Subjects must be post-op, having mild or moderate acute pain. Other inclusions apply.
Exclusion criteria
* 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 analgesic 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 has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication. * Subject is requiring treatment for pre-existing hypertension. Other exclusions apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | First dose to 30 days after the last dose | Safety Endpoints: * Treatment emergent AEs (TEAEs) * Serious adverse events (SAEs) * Withdrawals due to AEs * Deaths * Observed values and changes in vital sign measurements * Observed values and changes in clinical laboratory results * Physical examination findings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | From Baseline to 1st and 2nd hour | Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration. |
| Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | From Baseline to 1st and 2nd hour | Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zipsor® (Liquid Filled Capsules) Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Zipsor® (Liquid Filled Capsules) |
|---|---|
| Age, Continuous | 14.9 years STANDARD_DEVIATION 1.38 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
Safety Endpoints: * Treatment emergent AEs (TEAEs) * Serious adverse events (SAEs) * Withdrawals due to AEs * Deaths * Observed values and changes in vital sign measurements * Observed values and changes in clinical laboratory results * Physical examination findings
Time frame: First dose to 30 days after the last dose
Population: The Safety population included all subjects who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Treatment-emergent adverse events (TEAEs) | 12 participants |
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Severe TEAEs | 0 participants |
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Serious TEAEs | 1 participants |
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Serious Adverse Events (SAEs) | 1 participants |
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Withdrawals due to AEs | 0 participants |
| Zipsor® (Liquid Filled Capsules) | Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Deaths | 0 participants |
Secondary
Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.
Time frame: From Baseline to 1st and 2nd hour
Population: Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zipsor® (Liquid Filled Capsules) | Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | Baseline | 4.1 score on a scale | Standard Deviation 2 |
| Zipsor® (Liquid Filled Capsules) | Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | 1st Hour | 2.0 score on a scale | Standard Deviation 1.61 |
| Zipsor® (Liquid Filled Capsules) | Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | 2nd Hour | 1.7 score on a scale | Standard Deviation 1.77 |
Secondary
Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.
Time frame: From Baseline to 1st and 2nd hour
Population: Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zipsor® (Liquid Filled Capsules) | Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | Percent Change from baseline to 1 hour postdose | -55.32 Percent Change of NPRS Score | Standard Deviation 24.899 |
| Zipsor® (Liquid Filled Capsules) | Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | Percent Change from Baseline to 2 hours post dose | -60.25 Percent Change of NPRS Score | Standard Deviation 41.549 |