- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02542098
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
April 21, 2017 updated by: Purdue Pharma LP
A Phase 2B, Open-label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Effectiveness of Hydrocodone Bitartrate Extended-Release Tablets (HYD) in Children, Aged 12 to 17 Years Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Around-the-Clock Opioid Analgesics
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria include:
- 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.
Exclusion Criteria include:
- 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.
Other protocol-specific inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HYD 20 - 120 mg
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours
|
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of participants with adverse events as a measure of safety
Time Frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
|
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
Time Frame: Day 1, End of week 2, End of week 4
|
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
Time Frame: Day 1, End of week 2, End of week 4
|
Day 1, End of week 2, End of week 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
"Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS)
Time Frame: Day 1 up to week 4
|
Day 1 up to week 4
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Time Frame: Week 4 / end of treatment
|
Week 4 / end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2017
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
August 27, 2015
First Submitted That Met QC Criteria
September 2, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
April 24, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYD4002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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