An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain

NCT00766831 | Completed Phase 4 Results DMC

• 2 other identifiers: CR014806HYD-KOR-4002
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Pain

Keywords

Cancer pain; Hydromorphone OROS; Jurnista

Outcome Measures

Primary Outcomes (1)

• Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain

  Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.

  Day 15 or Early withdrawal

Secondary Outcomes (12)

• Sleep Disturbance Questionnaire: Analgesic Administration

  Baseline and Day 15

• Sleep Disturbance Questionnaire: Frequency of Waking Up

  Baseline and Day 15

• Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain

  Baseline and Day 15

• Korean Brief Pain Inventory (K-BPI) Questionnaire Score

  Baseline and Day 15

• Participant's Pain Intensity

  Baseline and Day 15

Study Arms (1)

Hydromorphone OROS

EXPERIMENTAL

Participants will receive hydromorphone OROS (8 milligram \[mg\] up 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.

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

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.

Also known as: Jurnista

Hydromorphone OROS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Cancer Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Medical Affairs

82-2-2094-4835

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 23, 2013
• Results First Posted: August 26, 2013

Record last verified: 2013-09