Trials / Withdrawn
WithdrawnNCT02542098
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Purdue Pharma LP · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HYD tablets | Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
- First posted
- 2015-09-04
- Last updated
- 2017-04-24
Source: ClinicalTrials.gov record NCT02542098. Inclusion in this directory is not an endorsement.