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

NCT ID: NCT02542098

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HYD 20 - 120 mg

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

Group Type: EXPERIMENTAL

HYD tablets

Intervention Type: DRUG

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

Interventions

HYD tablets

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

Intervention Type: DRUG

Other Intervention Names

Hysingla® ER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients must have stable vital signs and hemoglobin oxygen saturation, eg, measured by pulse oximetry (SpO2).

3. Patients must be willing and able to swallow medicinal tablets.

4. Female patients of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug treatment.

5. 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.

6. 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.

7. 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

1. Patients who require a starting total daily dose of HYD > 120 mg.

2. Patients who have had surgery within 72 hours prior to the start of study drug treatment.

3. Patients who have any planned surgery during the study will be excluded.

4. Female patients who are pregnant or lactating.

5. Patients who are allergic to hydrocodone or any other component of HYD or have a history of allergies to other opioids.

6. Patients who receive or are expected to receive an investigational drug/therapy during the study drug treatment or follow-up period.

7. 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.

8. Patients with a history of alcohol, medication, or illicit drug abuse or addiction and/or opioid abuse or addiction at any time.

9. Patients with contraindication to blood sampling.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HYD4002

Identifier Type: -

Identifier Source: org_study_id