PainPhase 2NCT02542098
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
A Phase 2 study testing HYD tablets in people with Pain, run by Purdue Pharma LP.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Pain
- What is being tested?
- HYD tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- HYD tablets
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYD tabletsDrug
Also called Hysingla® ER
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets.
| Study group | Role | What they receive |
|---|---|---|
| HYD 20 - 120 mg | Experimental | Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours Receives: Drug: HYD tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events as a measure of safety
Measured: 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
Measured: 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
Measured: Day 1, End of week 2, End of week 4
Secondary outcomes (2)
"Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS)
Measured: Day 1 up to week 4
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Measured: Week 4 / end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: Study has been updated with a new protocol number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542098
- Sponsor's protocol ID
- HYD4002
- Status last verified
- Apr 2017
- First submitted
- 27 Aug 2015
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02542098
- Acronym / sponsor ID
- HYD4002
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been updated with a new protocol number
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYD 20 - 120 mg | Experimental | Drug: HYD tabletsHydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYD tabletsAlso: Hysingla® ERHydrocodone bitartrate 20 mg to 120 mg extended-release tablets. | Drug | HYD 20 - 120 mg |
Primary outcome
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).
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
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
2 secondary outcomes
"Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS)
Time frame: Day 1 up to week 4
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Time frame: Week 4 / end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HYD tablets in people with Pain, run by Purdue Pharma LP.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.