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临床试验/EUCTR2007-000885-20-NL
EUCTR2007-000885-20-NL进行中(未招募)1 期

Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastased experiencing moderate to severe bone pain.

academic hospital Maastricht0 个研究点目标入组 53 人开始时间: 2007年5月11日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
53

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients with Malignant Bone Disease due to histology of cytology confirmed NSCLC.
  • MBD confirmed by bone scintigraphy, MRI, CT-scan, PET-scan or X-ray.
  • Mean bone pain score equal to or higher than 5.
  • Bone pain must correspond to areas of metastases on bone scinthigraphy, MRI, CT-scan, PET-scan of X-ray.
  • The use of at lease a NSAID or a weak opioid based on the WHO analgesic ladder step 2.
  • Age above 18 years.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Other active malignancies.
  • Nursing mothers.
  • Bone radiotherapy in the preceding 4 weeks

研究者

发起方
academic hospital Maastricht

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