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NCT00099177 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT00099177 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 96 participants.
The verdict
NCT00099177, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study Summary
This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG zoledronic acid
- DRUG ibandronate [Bondronat]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00099177
The ClinicalTrials.gov registry entry for NCT00099177 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which zoledronic acid is the first listed.
NCT00099177 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00099177 about?
NCT00099177 is a clinical study titled "A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain". This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bon...
What is the current status of trial NCT00099177?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2005-08. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00099177?
The interventions under investigation include: zoledronic acid (DRUG), ibandronate [Bondronat] (DRUG).
Who is sponsoring clinical trial NCT00099177?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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