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A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain

Information source: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer Pain

Intervention: Hydromprphone Hydrochloride (HCl) OROS (Drug); Morphine Sustain Release (SR) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Johnson & Johnson Taiwan Ltd

Official(s) and/or principal investigator(s):
Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Taiwan Ltd


The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

Clinical Details

Official title: A Randomized, Open-Labeled, Multi-Center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Comparing With Morphine SR in Cancer Pain Patients

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Brief Pain Inventory (BPI) Questionnaire Item 3 "Worst Pain" Score at Day 14

BPI Questionnaire Item 3 "Worst Pain" Score at Day 28

Secondary outcome:

BPI Questionnaire Item 6 "How Much Pain You Have Right Now" Score

BPI Questionnaire Item "Pain Intensity" Score

BPI Questionnaire Item "Pain Relief" Score

BPI Questionnaire Item "Pain Interference" Score

Patient's Global Assessment on Effectiveness

Investigator's Global Assessment on Effectiveness

Number of Times the Pain Medication Required for Breakthrough Pain

Mean Total Daily Dose (TDD) of Study Medication

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 [Day 1], Visit 2 [Day 1-13 telephonic], Visit 3 [Day 14], Visit 4 [Day 15 to Day 21 telephonic], Visit 5 [Day 22], Visit 6 [Day 23 to 27 telephonic] and Visit 7 [Day 28]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Participants with cancer pain and experiencing inadequate pain control on or

approaching Step 2 of the World Health Organisation (WHO) analgesic ladder

- Participants with pain scores greater than and equal to 4 on the average in the last

24 hours

- Participants requiring or are expected to require not more than 540 milligram of oral

morphine or morphine equivalent every 24 hours for the management of chronic cancer pain

- Participants who can reasonably be expected to achieve stable dose of opioid study

medication for the duration of the trial

- Participants who can reasonably be expected to achieve stable dose of opioid study

medication for the duration of the trial Exclusion Criteria:

- Participants with pure or predominantly neuropathic pain or pain of unknown origin

(where a mechanism or physical cause cannot be identified)

- Participants with acute pain or who have pain on movement

- Participants who have received a fentanyl patch within the last 5 days

- Participants intolerant or hypersensitive to hydromorphone or other opioids agonists

(chemical substance capable of activating a receptor to induce a full or partial response)

- Participants with recent past history (within the previous 5 years) or current

history of drug abuse or alcohol abuse

Locations and Contacts

Additional Information

Starting date: November 2008
Last updated: August 8, 2013

Page last updated: August 23, 2015

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