Chronic PainPhase 3NCT02321319
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
A Phase 3 study testing Hydromorphone HCl ER Tablets in people with Chronic Pain, run by Mallinckrodt at 3 sites in United States.
Trial summary
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic painful conditions who are "opioid-tolerant" prior to enrollment under the Pediatric Research… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Hydromorphone HCl ER Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Mar 2017to 4 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects aged 7 to 17 years.
- Chronic cancer or noncancer pain (requiring around-the-clock opioid treatment) currently managed with stable dose of oral or injectable opioid corresponding to at least 6 mg of hydromorphone per day for at least 5 days prior to first dose.
- Female subjects of child bearing potential must have negative serum pregnancy test result at Screening and Day 1. If sexually active must be surgically sterilized at least 12 months prior to Screening or use contraception at least 30 days prior to Screening and for the duration of study participation and for at least 30 days after the last dose of study drug.
- Male subjects, with reproductive potential, who are sexually active must agree to use an acceptable method of contraception for the duration of the study.
- Opioid-tolerant.
- Subjects must have established a favorable response to opioid therapy in reducing pain.
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- Subjects must require a minimum dose of 4 mg (1 JURNISTA tablet) and a maximum dose of 16 mg (1 EXALGO tablet) after determining 66% of the converted dose of hydromorphone HCl per day from an established conversion table.
- Able to swallow a whole tablet without breaking, crushing, chewing or dissolving.
- Expected to require extended opioid treatment for at least 1 week.
- Subjects must be able to communicate effectively with study personnel.
- Subjects and parents/legal guardian must be able and willing to follow all protocol requirements and study restrictions.
Who cannot join
- Life expectancy of less than 4 weeks.
- History of allergy or any significant intolerance with opioid treatment or allergies to sulfites.
- Currently using opioid (transcutaneous) analgesic patches.
- History of drug or alcohol dependence.
- History of renal, hepatic, cardiovascular, or respiratory conditions that would contraindicate participation in this study.
- Plan to undergo a surgical procedure within 3 days of Day 1 and for the duration of subject participation in the study. Subjects undergoing minor surgical procedures (eg, central line insertion, biopsies) will be eligible for participation in the study.
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- Exhibit hemodynamic instability.
- Have dysphagia, or difficulty swallowing whole tablets.
- Narrowing of the digestive tract, Short gut syndrome, inflammatory bowel disease, peritonitis, cystic fibrosis, Meckel's diverticulum, or past GI surgery.
- Hypothyroidism, Addison's disease, asthma (including exercise induced asthma) requiring daily inhalers, an enlarged prostate, epilepsy, low blood pressure, seizure disorder, high intracranial brain pressure, gallbladder problems, pancreatic disease, liver disease, or kidney disease.
- Ileostomy or paralytic ileus.
- Blood-product transfusion within 2 weeks of enrollment or expected to require transfusion during study.
- Participated in a study with an investigational drug or device in the past 30 days prior to screening.
- Known history of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jackson Memorial Hospital, University of Miami
Miami, Florida, 33136
Medical Professional Clinical Research
Miami, Florida, 33165
Clinical Pharmacology Services, Inc.
Tampa, Florida, 33617
About this study
Official title: An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic painful conditions who are "opioid-tolerant" prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.
- Conditions
- Chronic Pain
- Being tested
- Hydromorphone HCl ER Tablets
- Keywords
- Pediatric
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone HCl ER TabletsDrug
Also called Exalgo, Jurnista
Hydromorphone hydrochloride (HCl) extended release tablet
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone HCl ER Tablets | Experimental | Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids) Receives: Drug: Hydromorphone HCl ER Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start11 Mar 2017
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Why it stopped: Business decision - product discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321319
- Sponsor's protocol ID
- COV02520124
- Status last verified
- May 2020
- First submitted
- 12 Dec 2014
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain
- ClinicalTrials.gov ID
- NCT02321319
- Acronym / sponsor ID
- COV02520124
- Conditions
- Chronic Pain
- Keywords
- Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision - product discontinued
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic painful conditions who are "opioid-tolerant" prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone HCl ER Tablets | Experimental | Drug: Hydromorphone HCl ER TabletsParticipants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Male or female subjects aged 7 to 17 years.
- Chronic cancer or noncancer pain (requiring around-the-clock opioid treatment) currently managed with stable dose of oral or injectable opioid corresponding to at least 6 mg of hydromorphone per day for at least 5 days prior to first dose.
- Female subjects of child bearing potential must have negative serum pregnancy test result at Screening and Day 1. If sexually active must be surgically sterilized at least 12 months prior to Screening or use contraception at least 30 days prior to Screening and for the duration of study participation and for at least 30 days after the last dose of study drug.
- Male subjects, with reproductive potential, who are sexually active must agree to use an acceptable method of contraception for the duration of the study.
- Opioid-tolerant.
Key exclusion criteria (14 listed)
- Life expectancy of less than 4 weeks.
- History of allergy or any significant intolerance with opioid treatment or allergies to sulfites.
- Currently using opioid (transcutaneous) analgesic patches.
- History of drug or alcohol dependence.
- History of renal, hepatic, cardiovascular, or respiratory conditions that would contraindicate participation in this study.
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 |
|---|---|---|
| Hydromorphone HCl ER TabletsAlso: Exalgo, JurnistaHydromorphone hydrochloride (HCl) extended release tablet | Drug | Hydromorphone HCl ER Tablets |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 28 days
Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinical Study Leader study director
Mallinckrodt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydromorphone HCl ER Tablets in people with Chronic Pain, run by Mallinckrodt at 3 sites in United States.
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 11 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (AEs) (time frame: 28 days). 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 21 May 2020.