A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone
pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three
consecutive days) had great efficacy in reducing pain in patients with malignant bone
disease without unacceptable toxicities. So,we designed this clinical trial to compare the
efficacy and safety profiles between loading doses Bondronat and standard dose
Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on
three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120
individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean
pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome
measures will be efficacy including ECOG Performance status, analgesic consumption, bone
markers, and safety profiles including AE and laboratory parameters.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
1 month
No
Yilong Wu, MD
Principal Investigator
Guangdong Provincial People's Hospital
China: Food and Drug Administration
CSLC0701
NCT00492843
July 2007
July 2008
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