Evaluation of Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients.
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance |
- Improvement of the degree of sleep disturbance as measured by the K-BPI (question 9)
- 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
| Enrollment: | 121 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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 |
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 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT00766831 History of Changes |
| Other Study ID Numbers: | CR014806 |
| Study First Received: | October 3, 2008 |
| Last Updated: | October 7, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Cancer pain Hydromorphone Sleep Disturbance Numeric Rating scale |
Additional relevant MeSH terms:
|
Sleep Disorders Dyssomnias Parasomnias Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Hydromorphone Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013