Status:
COMPLETED
Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain
Lead Sponsor:
University Hospitals Bristol and Weston NHS Foundation Trust
Conditions:
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
RATIONALE: Oxycodone helps lessen pain caused by cancer and may improve quality of life. It is not yet known whether oxycodone works better and is more cost effective than standard therapy in treating...
Detailed Description
OBJECTIVES: Primary * Compare overall pain management in patients with cancer-related pain treated with oxycodone hydrochloride vs standard three-step analgesic therapy. * Compare the health economi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Requires regular step-2 analgesia for the management of cancer-related pain
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must be able to take oral medication
- Must be willing and able to complete a daily patient assessment booklet (PAB)
- No history of the following conditions:
- Depression
- Personality disorders that may lead to self-harm
- Admission to the hospital for psychiatric reasons
- Any other psychological disorder that, in the opinion of the investigator, would preclude study treatment
- Not at risk of additional CNS depressant effects due to study drugs
- No known history of alcohol or drug abuse or, in the opinion of the investigator, tendency towards drug abuse or addiction
- No current abuse of alcohol or drugs
- No known sensitivity to oxycodone hydrochloride or other opioids
- No history of a specific or allergic reaction to study drugs
- No contraindications as a result of adverse drug reaction or drug interactions of oxycodone or other opioid drugs
- No other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation
- PRIOR CONCURRENT THERAPY:
- More than 30 days since prior and no concurrent chemotherapy or radiotherapy
- At least 2 weeks since prior regular (i.e., 4 times per day) step-2 analgesics
- More than 3 months since prior regular use of opioids, defined as having a regular prescription of an opioid medication
- Not planning to undergo cancer-related surgery
- No other concurrent opioid-based medication other than oxycodone hydrochloride capsules as escape medication (arm II)
- No concurrent participation in another clinical trial involving a new chemical entity
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00378937
Start Date
January 1 2004
End Date
February 1 2006
Last Update
August 2 2013
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