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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01982539
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Depomed

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Zipsor®
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zipsor® (Liquid Filled Capsules)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Zipsor® (Liquid Filled Capsules)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
14.9  (1.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
9
  36.0%
Male
16
  64.0%
1.Primary Outcome
Title To Confirm the Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
Hide 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
Time Frame First dose to 30 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received at least 1 dose of the study drug.
Arm/Group Title Zipsor® (Liquid Filled Capsules)
Hide Arm/Group Description:
Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Treatment-emergent adverse events (TEAEs) 12
Severe TEAEs 0
Serious TEAEs 1
Serious Adverse Events (SAEs) 1
Withdrawals due to AEs 0
Deaths 0
2.Secondary Outcome
Title Efficacy
Hide Description To determine efficacy by assessing percent changes of 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.
Time Frame From Baseline to 1st and 2nd hour
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zipsor® (Liquid Filled Capsules)
Hide Arm/Group Description 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.
All-Cause Mortality
Zipsor® (Liquid Filled Capsules)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zipsor® (Liquid Filled Capsules)
Affected / at Risk (%)
Total   1/25 (4.00%) 
Injury, poisoning and procedural complications   
Post Procedural Bile Leak  1/25 (4.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zipsor® (Liquid Filled Capsules)
Affected / at Risk (%)
Total   9/25 (36.00%) 
Gastrointestinal disorders   
Nausea  5/25 (20.00%) 
Constipation  2/25 (8.00%) 
Nervous system disorders   
Headache  2/25 (8.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Depomed
Phone: 510-744-8000
EMail: clinicaltrials@depomed.com
Layout table for additonal information
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01982539     History of Changes
Other Study ID Numbers: 81-0072
First Submitted: November 1, 2013
First Posted: November 13, 2013
Results First Submitted: April 30, 2015
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015