Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children

NCT02542098 | Withdrawn Phase 2 DMC

• 1 other identifier: HYD4002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• The number of participants with adverse events as a measure of safety

  Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).

• Pharmacokinetic analysis to characterize the apparent volume of distribution (Vc/F) of hydrocodone following oral administration

  Day 1, End of week 2, End of week 4

• Pharmacokinetic analysis to characterize the apparent oral clearance (CL/F) of hydrocodone following oral administration

  Day 1, End of week 2, End of week 4

Secondary Outcomes (2)

• "Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS)

  Day 1 up to week 4

• Parent/ Caregiver-Assessed Global Impression of Change (PGIC)

  Week 4 / end of treatment

Study Arms (1)

HYD 20 - 120 mg

EXPERIMENTAL

Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours

Drug: HYD tablets

Interventions

HYD tablets DRUG

Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets.

Also known as: Hysingla® ER

HYD 20 - 120 mg

Eligibility Criteria

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

You may qualify if:

• Males and females, aged 12 to 17 years, with pain severe enough to require daily, around-the-clock opioid treatment at a dose equivalent to at least 20 mg daily of hydrocodone for at least 2 weeks.
• Patients must have stable vital signs and hemoglobin oxygen saturation, eg, measured by pulse oximetry (SpO2).
• Patients must be willing and able to swallow medicinal tablets.
• Female patients of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug treatment.
• Female patients who are sexually active must be using (and continue using throughout the study) an acceptable method of birth control, per investigator's discretion.
• Patients and patient's parent/caregiver must be compliant with the protocol, ie, must be able to perform study assessments and understand and complete the age-appropriate scale to rate pain intensity.
• Patients must not have a cognitive developmental delay or any other condition that would preclude them from completing the age-appropriate pain scale.

You may not qualify if:

• Patients who require a starting total daily dose of HYD \> 120 mg.
• Patients who have had surgery within 72 hours prior to the start of study drug treatment.
• Patients who have any planned surgery during the study will be excluded.
• Female patients who are pregnant or lactating.
• Patients who are allergic to hydrocodone or any other component of HYD or have a history of allergies to other opioids.
• Patients who receive or are expected to receive an investigational drug/therapy during the study drug treatment or follow-up period.
• Patients who are anticipated to receive any hydrocodone- or hydromorphone-containing products (other than study drug) during the study or 3 days prior to initiation of treatment with study drug.
• Patients with a history of alcohol, medication, or illicit drug abuse or addiction and/or opioid abuse or addiction at any time.
• Patients with contraindication to blood sampling.

Sponsors & Collaborators

• Purdue Pharma LP: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 4, 2015
• Study Start: January 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 24, 2017

Record last verified: 2017-04