Clinical trial · Interventional
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain
NCT01982539CI-TRIAL-00044981completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zipsor® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zipsor® (Liquid filled capsules)
- description
- 25mg/every 6hrs/up to 4 days treatment
- interventionNames
- Drug: Zipsor®
Primary outcomes (1)
- measure
- Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
- timeFrame
- First dose to 30 days after the last dose
- description
- 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 outcomes (2)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.