Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydromorphone HCl ER Tablets
Intervention description: Hydromorphone hydrochloride (HCl) extended release tablet
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric

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 Equity Act (PREA) of 2003.
    

Eligibility criteria:

        Inclusion:

          1. Male or female subjects aged 7 to 17 years.

          2. 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.

          3. 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.

          4. Male subjects, with reproductive potential, who are sexually active must agree to use
             an acceptable method of contraception for the duration of the study.

          5. Opioid-tolerant.

          6. Subjects must have established a favorable response to opioid therapy in reducing
             pain.

          7. 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.

          8. Able to swallow a whole tablet without breaking, crushing, chewing or dissolving.

          9. Expected to require extended opioid treatment for at least 1 week.

         10. Subjects must be able to communicate effectively with study personnel.

         11. Subjects and parents/legal guardian must be able and willing to follow all protocol
             requirements and study restrictions.

        Exclusion:

          1. Life expectancy of less than 4 weeks.

          2. History of allergy or any significant intolerance with opioid treatment or allergies
             to sulfites.

          3. Currently using opioid (transcutaneous) analgesic patches.

          4. History of drug or alcohol dependence.

          5. History of renal, hepatic, cardiovascular, or respiratory conditions that would
             contraindicate participation in this study.

          6. 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.

          7. Exhibit hemodynamic instability.

          8. Have dysphagia, or difficulty swallowing whole tablets.

          9. Narrowing of the digestive tract, Short gut syndrome, inflammatory bowel disease,
             peritonitis, cystic fibrosis, Meckel's diverticulum, or past GI surgery.

         10. 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.

         11. Ileostomy or paralytic ileus.

         12. Blood-product transfusion within 2 weeks of enrollment or expected to require
             transfusion during study.

         13. Participated in a study with an investigational drug or device in the past 30 days
             prior to screening.

         14. Known history of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
             hepatitis B virus.