Clinical trial
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced…
NCT00101582 · Swedish Orphan Biovitrum, Industry · Completed
Key facts
| NCT number | NCT00101582 |
|---|---|
| Title | Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer |
| Official title | Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT) |
| Lead sponsor | Swedish Orphan Biovitrum, Industry |
| Collaborators | Amgen Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer, Squamous Cell Carcinoma |
| Intervention type | Drug, Radiation |
| Interventions | Placebo, palifermin, cisplatin chemotherapy, Radiotherapy |
| Enrollment | 188 |
| Start date | Aug 1, 2005 |
| Primary completion | Sep 1, 2007 |
| Completion | Aug 1, 2016 |
| First posted | Jan 13, 2005 |
| Last update posted | Sep 27, 2016 |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: