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

NCT01982539 | Completed Phase 4 Results

• 1 other identifier: 81-0072
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

pain; NSAID; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  From Baseline to 1st and 2nd hour

• 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.

  From Baseline to 1st and 2nd hour

Study Arms (1)

Zipsor® (Liquid filled capsules)

EXPERIMENTAL

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

Drug: Zipsor®

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.

Also known as: Diclofenac

Zipsor® (Liquid filled capsules)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects between 12-17 years of age.
• Subjects must be post-op, having mild or moderate acute pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Depomed: lead

Study Sites (2)

Unknown Facility

Sheffield, Alabama, 35660, United States

Location

Unknown Facility

Stanford, California, 94305-5640, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain; Lymphoma, Follicular

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Clinical Operations
• Organization: Depomed

clinicaltrials@depomed.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 7, 2020
• Results First Posted: May 15, 2015

Record last verified: 2020-04

Locations

US (2)