Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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 patients with cancer pain.

PURPOSE: This randomized phase IV trial is studying oxycodone to see how well it works compared with standard pain therapy in treating patients with cancer pain and if it is more cost effective than standard pain therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust; University Hospitals Bristol NHS Foundation Trust
• Treatments: Acetaminophen; Codeine; Dextropropoxyphene; Levopropoxyphene; Morphine; Oxycodone

Criteria

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