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Valdecoxib in Treating Chronic Pain in Cancer Patients

Pain Clinical Trial

Official title:
Clinical Protocol for a Randomized Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-On Therapy to Opioid Medication in Patients With Chronic Cancer Pain

Clinical Trial Summary

RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is not yet known if valdecoxib is effective in treating chronic pain.

PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving chronic pain in cancer patients.

Clinical Trial Description

OBJECTIVES: I. Assess the analgesic efficacy of valdecoxib administered in addition to opioid medication in patients with chronic pain due to cancer or prior cancer therapy. II. Assess the safety of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to baseline average pain intensity score (2-4 vs 5-11). Patients are randomized to 1 of 2 treatment arms. Patients undergo a pretreatment period of 3-14 days to determine daily dose of sustained release and immediate release opioid medications required to adequately control pain with tolerable side effects. Arm I: Patients receive oral valdecoxib twice daily in addition to opioid medications. Arm II: Patients receive oral placebo twice daily in addition to opioid medications. Treatment continues for a maximum of 12 weeks in the absence of inadequate pain control or unacceptable toxicity. Patients record daily pain assessments and total daily opioid consumption. Patients also are contacted by telephone weekly for assessment of pain, opioid use, and adverse effects.

PROJECTED ACCRUAL: A maximum of 260 patients will be accrued for this study. ;

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
Clinical Trial Details
NCT number NCT00021996
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase N/A
Start date January 2001
Completion date February 2004
View Details
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