Oxycodone or Standard Pain Therapy in Treating Patients With Cancer Pain

NCT00378937 | Completed Phase 4

• 5 other identifiers: CRUK-ON/2003/1772CDR0000507650EU-20640EUDRACT-2004-004235-66NAPP-CRUK-ON/2003/1772
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• Percentage of time in assessment periods 1 and 2 (i.e., first 4 weeks) with a Box-Scale (BS)-11 pain score of ≤ 4 (i.e., mild pain)

Secondary Outcomes (8)

• Percentage of time in assessment periods 3 and 4 with a BS-11 pain score of ≤ 4

• Mean BS-11 pain scores

• Time to reach stable pain control

• Mean escape medication use

• Quality of sleep

Interventions

acetaminophen DRUG

codeine phosphate DRUG

dextropropoxyphene hydrochloride DRUG

morphine sulfate DRUG

oxycodone hydrochloride DRUG

management of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Codeine; Levopropoxyphene; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Geoff Hanks, MD

  University Hospitals Bristol and Weston NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: January 1, 2004
• Study Completion: February 1, 2006
• Last Updated: August 2, 2013

Record last verified: 2007-07