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Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

Phase 4
20 Years
Not Enrolling

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Trial Information

Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

Effective pain relief and high sleep quality allow patients to resume active lives and be
themselves. This is multicenter, prospective, open-label, single-arm, dose-ascending study
to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep
disturbance provoked by cancer pain. Patient who took oral opioid previously will be
administered the study drug for two weeks. Primary Endpoint is improvement of the degree of
sleep disturbance as measured by the K-BPI (question 9). Secondary Endpoint are as follows:
K-BPI (Korean Brief Pain Inventory: 9-questionnaire, 11-point scale), Pain intensity at
morning and afternoon, Number of breakthrough pain medication, Investigator and patient
global assessments: 5-pint rating scale, Patient's preference, CGI-I (Clinical Global
Impression - Improvement: 7 point rating scale), Safety evaluation(adverse event &
tolerance) Initial Dose of Hydromorphone OROS: At second visit, initial dose of
hydromorphone will be determined according to the equivalent analgesic effect conversion
table. Subject will administer hydromorphone at 10 AM. At Change of Hydromorphone dose: The
investigator will increase a patient's daily dose if more than 3 breakthrough pain episodes
requiring rescue medication occurred within 24 hours. Daily doses will be titrated up to the
next higher dose level every 2 days after phone call

Inclusion Criteria:

- Patients who are currently receiving strong opioid analgesic for their cancer pain

- Patients who are able, in the opinion of investigator, to comply fully with the trial
requirements including completion of the Korean-Brief Pain Inventory

- Patients who have signed an informed consent form

Exclusion Criteria:

- Patients with pain that was not considered to be potentially responsive to opioids

- A recent (within the past 6 months) or currently history of drug and/or alcohol abuse

- Women of childbearing potential who are pregnant or lactating, seeking pregnancy, or
failing to take adequate contraceptive precautions

- Patients with an intolerant of, or hypersensitivity to, hydromorphone or other

- Patients with GI disease of sufficient severity to be likely to interfere with oral
analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due
to impaction within 5 days of the study, severe gut narrowing or factors predisposing
to gut narrowing (both hereditary or iatrogenic [e.g. GI surgery or GI radiotherapy])
that may affect the absorption or transit of orally administered drugs, particularly
the insoluble OROS outer coating

- Patients who were receiving or had received monoamine oxidase inhibitors (MAOIs)
within the past 2 weeks

- Patients who had previously enrolled in this trial

- Patients who had participate in another trial with an investigational drug in the
last 4 weeks

- Patients in whom the risks of treatment with morphine/hydromorphone outweighed the
potential benefits, including such risk categories as raised intracranial pressure,
hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic
hypertrophy, hepatic impairment, renal impairment, elderly and debilitated,
convulsive disorders, and Addison's disease.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement of the degree of sleep disturbance as measured by the K-BPI (question 9)

Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.


Korea: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

June 2010

Related Keywords:

  • Pain
  • Cancer pain
  • Hydromorphone
  • Sleep Disturbance
  • Numeric Rating scale
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias