search
Back to results

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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zipsor®
Sponsored by
Depomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zipsor® (Liquid filled capsules)

Arm Description

25mg/every 6hrs/up to 4 days treatment

Outcomes

Primary Outcome Measures

Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
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 Outcome Measures

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.
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.
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.
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.

Full Information

First Posted
November 1, 2013
Last Updated
April 27, 2020
Sponsor
Depomed
search

1. Study Identification

Unique Protocol Identification Number
NCT01982539
Brief Title
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Depomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zipsor® (Liquid filled capsules)
Arm Type
Experimental
Arm Description
25mg/every 6hrs/up to 4 days treatment
Intervention Type
Drug
Intervention Name(s)
Zipsor®
Other Intervention Name(s)
Diclofenac
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
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
Secondary Outcome Measure Information:
Title
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.
Description
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at 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
Title
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.
Description
Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5640
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs