An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Condition: Cancer Pain
MeSH terms: Cancer Pain
Intervention: Hydromorphone
Intervention description: Participants will receive hydromorphone OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS will be continued as per Investigator's discretion for additional 84 days of extension phase.
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Cancer pain; Hydromorphone OROS; Jurnista

Summary:

      The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain
      after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants
      with cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are currently receiving strong opioid analgesic (drug used to control
             pain) for their cancer pain management

          -  Participants whose arithmetical mean of sleep disturbance caused by pain measured with
             Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4
             points

          -  Participants who are able, in the opinion of Investigator, to comply fully with the
             trial requirements including completion of the Korean-Brief Pain Inventory

          -  Participants who have signed an informed consent form

        Exclusion Criteria:

          -  Participants with pain who are not likely to response to opioid analgesics

          -  Participants who are intolerant or hypersensitive to hydromorphone

          -  Participants with the following digestive tract diseases which is serious enough to
             interfere action of an oral analgesic; diseases which can affect absorption and
             transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel
             movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct,
             tube, or 1 of the valves in the heart), etc

          -  Female participants of childbearing potential who are pregnant or lactating, seeking
             pregnancy, or failing to take adequate contraceptive precautions

          -  Participants in whom the risks of treatment with morphine/hydromorphone outweigh the
             potential benefits, including such risk categories as raised intracranial pressure,
             hypotension, hypothyroidism, asthma, compromised respiratory function compromised
             liver function, convulsive (an involuntary contraction or series of contractions of
             the voluntary muscles) disorder and Addison disease (disorder that occurs when the
             adrenal glands do not produce enough of their hormones)