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Trial record 18 of 145 for:    Hydrocodone

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

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ClinicalTrials.gov Identifier: NCT02542098
Recruitment Status : Withdrawn (Study has been updated with a new protocol number)
First Posted : September 4, 2015
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: HYD tablets Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HYD 20 - 120 mg
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours
Drug: HYD tablets
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets.
Other Name: Hysingla® ER




Primary Outcome Measures :
  1. 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). ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. "Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS) [ Time Frame: Day 1 up to week 4 ]
  2. Parent/ Caregiver-Assessed Global Impression of Change (PGIC) [ Time Frame: Week 4 / end of treatment ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  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 include:

  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.

Other protocol-specific inclusion/exclusion criteria may apply.


Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT02542098     History of Changes
Other Study ID Numbers: HYD4002
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hydrocodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents