A Randomised, Open-labeled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCL Comparing With Morphine SR in Cancer Pain Patients
18 Years
N/A
Both
Pain
Trial Information
A Randomised, Open-labeled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCL Comparing With Morphine SR in Cancer Pain Patients
This is a phase III, randomized, open-labeled, active-controlled, multi-center study in 110
adult patients with cancer pain, requiring strong oral opioid analgesics. This study period
is divided into 3 phases: screening period (14 days prior to randomization/dosing), dose
titration phase (3 to 14 days), and dose maintenance phase (14 days). Patients will be
evaluated at 4 scheduled clinic visits and contacted by telephone daily between visit. The
screening will last up to two weeks. Patients with cancer pain who meet entrance criteria
for the study will be identified. The study will be explained and informed consent will be
obtained. Patients who have met the criteria at screening will start approximately 17-28
days treatment of either OROS hydromorphone or Morphine SR (sustain release). During the
treatment, dose adjustments are permitted in steps at titration. Dose level may be titrated
upwards or downwards every 48 hours in the titration phase. The dose should be titrated by
the Investigator according to the patient's analgesic requirement. A patient is considered
stabilized when, for a minimum of 2 consecutive days, the requirements of rescue medication
are maintained at 3 doses per day or less. If necessary, dose titration is also permitted
during maintenance phase using the same criteria used in the titration phase. Patients
should be titrated to adequate effect no more frequently than every 2 days in maintenance
phase. Morphine hydrochloride will be used as rescue medication for breakthrough pain. No
other opioid is permitted during treatment period. Adjuvant medications such as paracetamol,
non-steroidal anti-inflammatory drugs, anxiolytics, antidepressants, antiarrhythmic drugs,
hormone therapy, corticosteroids, anticonvulsants, and neuroleptics are allowed but must be
maintained at stable doses for the duration of the trial. Analgesic efficacy is assessed
using the short form of the Brief Pain Inventory (BPI). Equivalence of efficacy will be
assessed using the "worst pain" item of the BPI (BPI Question 3) as the primary efficacy
assessment. BPI Q3 & Q6 (Question 3 & 6), study medication usage, and requirements of rescue
medication will be recorded daily by patients for both treatment groups. Other pain
assessments in the BPI will be performed by patients and the Investigator at 4 visits
(baseline/randomization, Visit 3 and 5, and FINAL visit). And Global assessments will be
performed by patients and the Investigator at 3 visits (Visit 3 and 5, and FINAL visit).
Safety will also be assessed through physical examinations and vital signs, clinical
laboratory evaluation, and monitoring for adverse events. Patients who have met the
criteria at screening will start approximately 17-28 days treatment of either OROS
hydromorphone or oral Morphine SR. During the treatment, dose adjustments are permitted in
steps at titration. The dose should be titrated by the Investigator according to the
patient's analgesic requirement. For patients not routinely receiving opioids, the initial
dose should not exceed 8 mg OROS hydromorphone every 24 hours (in the morning) or 30 mg
Morphine SR twice daily.
Inclusion Criteria:
- Patients who are experiencing inadequate pain control on or approaching step 2 of the
WHO analgesic ladder
- Patients whose pain scores >= 4 on the average in the last 24 hours
- Patients who require or are expected to require not more than 540 mg of oral morphine
or morphine equivalent every 24 hours for the management of chronic cancer pain
- Patients who can reasonably be expected to achieve stable dose of opioid study
medication for the duration of the trial.
Exclusion Criteria:
- Patients with pure or predominantly neuropathic pain or pain of unknown origin (where
a mechanism or physical cause can not be identified)
- Patients with acute pain
- Patients who have received a fentanyl patch within the previous 5 days
- Patients with any gastrointestinal (GI) disorder or surgical procedure that would
result in narrowing of the GI tract, "blind loops" of the GI tract, gastrointestinal
obstruction, or sudden and significant shortening of GI transit time such as: prior
gastrointestinal surgery (eg, vagotomy, antrectomy, pyroloplasty, gastroplasty,
gastrojejunostomy) or gastrointestinal disease resulting in impaired gastrointestinal
function (eg, paralytic ileus, gastroparesis, inflammatory bowel disease or
obstructive bowel disorders, "short gut" syndrome due to adhesions or decreased
transit time, biliary tract disease or planned biliary surgery, acute pancreatitis
secondary to biliary tract disease, past history of peritonitis, cystic fibrosis,
chronic intestinal pseudoobstruction, or Meckel diverticulum)
- Patients with acute abdominal conditions that may be obscured by opioids (such as,
intestinal occlusion, especially of the ileus)
- Patients with any CNS disorder, including but not limited to head injury,
intracranial lesion, increased intracranial pressure, seizure disorder, stroke within
the previous 6 months, and disorder of cognition, which would interfere with the
completion of patient assessments and study compliance. (Patients with cerebral
metastases, which in the opinion of the Investigator do not preclude the use of
strong opioids, may be included.)
- Patients who may have been at risk for significant decreases in blood pressure upon
administration of an opioid analgesic (depleted blood volume, compromised vasomotor
to tone, circulatory shock)
- Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any
other disorder that predisposes the patient to CO2 retention or respiratory
depression
- Patients who have received monoamine oxidase inhibitors, radiotherapy for pain
relief, neuro-ablative or anesthetic procedures including acupuncture, surgical
procedures relevant to cancer pain within 14 days prior to the screening visit
- Patients with any clinically significant laboratory test result (chemistry,
hematology, or urinalysis) including BUN or creatinine values >=1.5 times ULN (upper
normal limit) or ALT/AST values >= 5 times ULN.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To demonstrate the clinical equivalence of efficacy between OROS hydromorphone HCI and Morphine SR in patients with cancer pain at baseline, visit 3, 5 and final visit.
Principal Investigator
Johnson & Johnson Taiwan, Ltd. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Taiwan Ltd
Authority:
Taiwan: Food & Drug Administration
Study ID:
CR015328
NCT ID:
NCT00803283
Start Date:
August 2008
Completion Date:
December 2008
Related Keywords:
- Pain
- Pain
- Oros hydromorphone HCL
- Cancer pain
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