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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982539
• Other study ID #: 81-0072
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2020
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First dose to 30 days after the last dose
Secondary	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.	From Baseline to 1st and 2nd hour
Secondary	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.	From Baseline to 1st and 2nd hour