At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Zipsor®drug
Likely dose
Zipsor® 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Zipsor® for Pain. Completed, enrolled 25 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedNov 2013
Primary CompletionMay 2014
Study CompletionSep 2014
TodayJul 2026
First PostedNov 13, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago
Interventions
Zipsor®drug
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.