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This is a Randomised, Open-labeled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCL Comparing With Morphine SR (Sustain Release) in Cancer Pain Patients.

Information source: Johnson & Johnson Taiwan Ltd
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: OROS hydromorphone (Drug)

Phase: Phase 3

Status: Not yet recruiting

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

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

Summary

The purpose of this trial is to evaluate whether in the treatment of Taiwan patients with cancer pain on or approaching step 2 of the WHO ladder, a novel once daily SR (sustain release), OROS osmotic technology, extended-release (ER) hydromorphone formulation is equivalent to twice daily Morphine SR (sustain release).

Clinical Details

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: Other assessments of pain from the BPI;Global assessments of effectiveness by the patient and Investigator;Use of breakthrough pain medication;Percentage of patients discontinued the study will be assessed at baseline, visit 3, 5 and final visit.

Detailed description: 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.

Eligibility

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

Criteria:

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.

Locations and Contacts

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

Additional Information


Ending date: December 2009
Last updated: September 25, 2009

Page last updated: October 19, 2009

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