Status:
COMPLETED
An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Cancer Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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.
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) dose-ascending stud...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00766831
Start Date
October 1 2008
End Date
June 1 2010
Last Update
October 23 2013
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