Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021996
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-08-10
Brief Title:
Valdecoxib in Treating Chronic Pain in Cancer Patients
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
PURPOSE Randomized clinical trial to study the effectiveness of valdecoxib in relieving chronic pain in cancer patients
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SC-N91-00-02-040 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068670 | REGISTRY | None | None |
| BWH-2000-P-0009847 | None | None | None |