Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
Tracking Information | |||||
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First Received Date ICMJE | June 25, 2007 | ||||
Last Updated Date | June 9, 2008 | ||||
Start Date ICMJE | July 2007 | ||||
Estimated Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) [ Time Frame: 1 month ] | ||||
Change History | Complete list of historical versions of study NCT00492843 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters [ Time Frame: 1 month ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Lung Cancer | ||||
Intervention ICMJE | Drug: Ibandronate (Bondronat)
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Other Name: no other names |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 20 | ||||
Estimated Completion Date | July 2008 | ||||
Estimated Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | China | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492843 | ||||
Other Study ID Numbers ICMJE | CSLC0701 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Chinese Society of Lung Cancer | ||||
Study Sponsor ICMJE | Chinese Society of Lung Cancer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Chinese Society of Lung Cancer | ||||
Verification Date | June 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |