Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02321319
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Hydromorphone HCl ER Tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Hydromorphone HCl ER Tablets
Hydromorphone HCl ER Tablets 4 mg, 8 mg, 12 mg, or 16 mg
Drug: Hydromorphone HCl ER Tablets
Other Name: Exalgo, Jurnista

Primary Outcome Measures :
  1. Safety ( based on vital signs, pulse oximetry, clinical laboratory assessments, and AEs) [ Time Frame: 28 days ]
    Safety based on vital signs, pulse oximetry, clinical laboratory assessments, and AEs

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02321319

Contact: Amy O'Brien 314-654-3221

United States, Florida
Jackson Memorial Hospital, University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Juan Gutierrez    305-585-8365   
Principal Investigator: Ralf Gebhard, MD         
Medical Professional Clinical Research Recruiting
Miami, Florida, United States, 33165
Contact: Analay Rico    786-953-8115   
Principal Investigator: Maria Vazquez, MD         
Clinical Pharmacology Services, Inc. Recruiting
Tampa, Florida, United States, 33617
Contact: Agnes Besser    813-983-1501   
Principal Investigator: Daniel Buffington, PhD         
Sponsors and Collaborators

Responsible Party: Mallinckrodt Identifier: NCT02321319     History of Changes
Other Study ID Numbers: COV02520124
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by Mallinckrodt:
chronic pain

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents