Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
Phase 2
Withdrawn
- Conditions
- Pain
- Interventions
- Drug: HYD tablets
- Registration Number
- NCT02542098
- Lead Sponsor
- Purdue Pharma LP
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HYD 20 - 120 mg HYD tablets Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method "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