E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of pain in breast cancer patients with bone metastases |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the Pain Response of ibandronic acid on day 7 compared to baseline in breast cancer patients with painful bone metastases. |
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E.2.2 | Secondary objectives of the trial |
Secondary variables: - worst pain in movement and rest on NRS - average pain in movement and rest on VAS and NRS - worst and average pain in movement and in rest on VAS recorded in a diary -consumption of analgesics recorded in a diary
Quality of life variables - WHO PS - EORTC QLQ C30
Safety variables - Adverse Events
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histological or cytological evidence of breast cancer - Presence of bone metastases documented on bone x-ray, bone scintigram, CT scan or MRI scan before inclusion into the trial. - Worst pain score in movement or in rest of ≥ 4 on the VAS during the previous 24 hours before the Screening visit. - After the optimization of the analgesic dose worst pain score in movement or in rest of ≥ 4 on the VAS during the previous 24 hours before the visit on Day 1. - Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; patients, whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to ensure that each patient’s pain is primarily due to bone metastases. - The use of at least a weak opioid based on the WHO analgesic ladder (Appendix 7) during the baseline period
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E.4 | Principal exclusion criteria |
• Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of ibandronate dosing • Patients with an impending pathological fracture • Patients with known medulla compression. • Patients, who have received an intravenous bisphosphonate within 4 weeks before baseline/screening. • Patients with known hypersensitivity to any of the components of ibandronate • Patients, who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication in any country.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain variables Primary variable: - worst pain in movement and rest on VAS
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |