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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 September 2015 |
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Main ID: |
NCT02553707 |
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Date of registration:
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16/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
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Scientific title:
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Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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182 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02553707 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female participants greater than or equal to (>=) 18 years of age
- Breast cancer with bone metastases
- Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
- Stable analgesic regimen.
Exclusion Criteria:
- Participants who have received a bisphosphonate within 3 weeks of start of trial
- Radiotherapy to bone within 4 weeks of enrolment
- Hypersensitivity to ibandronate
- Central nervous system (CNS) or meningeal metastases
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pain; Bone Neoplasms; Neoplasm Metastasis
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Intervention(s)
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Drug: Ibandronate
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Primary Outcome(s)
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Percentage of participants with >=25% reduction in mean pain
[Time Frame: up to Day 6]
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Percentage of participants with =<35% increase in mean analgesic consumption
[Time Frame: up to Days 7]
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Secondary Outcome(s)
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Pain response
[Time Frame: up to Day 7]
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Change from Baseline in average pain score
[Time Frame: Baseline (Days 0), 5, and 7]
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Time to pain response
[Time Frame: up to Day 7]
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Analgesic consumption
[Time Frame: up to Day 7]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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