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Evaluation of Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients.
This study is not yet open for participant recruitment.
Verified by Janssen Korea, Ltd., Korea, December 2008
Sponsored by: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00766831
  Purpose

The purpose of this study is to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance provoked by cancer pain.


Condition Intervention Phase
Pain
Drug: Hydromorphone Hydrochloride
Phase IV

MedlinePlus related topics: Cancer Sleep Disorders
Drug Information available for: Hydromorphone Hydromorphone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Improvement of the degree of sleep disturbance as measured by the K-BPI (question 9)

Secondary Outcome Measures:
  • K-BPI (Korean Brief Pain Inventory: 9-questionnaire, 11-point scale), Pain intensity at AM & PM, Number of breakthrough pain medication, Investigator and patient global assessments: 5-pint rating scale, Patient's preference, CGI-I (Clinical Global

Estimated Enrollment: 134
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are currently receiving strong opioid analgesic for their cancer pain management
  • 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 opioids
  • 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 radiotiotherapy]) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766831

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

Locations
Korea, Republic of
PuSan, Korea, Republic of
UlSan, Korea, Republic of
JinJu, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Responsible Party: Janssen Korea, Ltd., Korea ( Medical Director )
Study ID Numbers: CR014806
Study First Received: October 3, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00766831  
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Cancer pain
Numeric Rating scale
Sleep Disturbance
Hydromorphone

Study placed in the following topic categories:
Hydromorphone
Dyssomnias
Sleep Disorders
Pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009