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Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute

NCT01982539 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-05-07

Study results available
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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.

Conditions

Interventions

DRUG

Zipsor®

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 & Collaborators

  • Depomed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982539 on ClinicalTrials.gov