Phase 4
N=25
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01982539 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
May 2015
Primary outcome: Primary: Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years — 12; 0; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zipsor® (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Depomed
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years |
12; 0; 1; 1; 0; 0 | — |
| 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. |
4.1; 2.0; 1.7 | — |
| 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. |
-55.32; -60.25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01982539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.