A Phase 4 interventional study of acetaminophen and codeine phosphate in Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University Hospitals Bristol and Weston NHS Foundation Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by University Hospitals Bristol and Weston NHS Foundation Trust · Phase 4, Interventional, and Supportive care
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, randomized, parallel group, pilot study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive an analgesic regimen, according to their level of pain, for up to 18 weeks.
Patients may also receive an adjuvant drug (i.e., for side effects or for primary indication other than pain management that is analgesic in selected circumstances).
Patients in both arms may also receive additional medication for breakthrough pain.
Patients complete a patient-assessment booklet (PAB) daily which includes a Box-Scale (BS)-11 rating for average pain; questions regarding contact (e.g., telephone or visit) with healthcare professionals on that day; and information regarding the number of times escape medication is used.
Quality of life and levels of cancer pain are assessed using the short form of the Brief Pain Inventory (BPI).
After completion of study treatment, patients are followed at 4 weeks.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →University Hospitals Bristol and Weston NHS Foundation Trust is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No history of the following conditions:
PRIOR CONCURRENT THERAPY:
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)
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
Global assessment of pain relief with study drugs
Mean pain intensity, pain interference, and pain relief scores as measured by the Brief Pain Inventory
Overall number of phone calls, home visits by a nurse, home visits by a doctor, and unscheduled visits to a healthcare provider, related to pain control or analgesic medication during study treatment
No study locations are listed for this record.
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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University Hospitals Bristol and Weston NHS Foundation Trust