Clinical trial
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation…
NCT00109031 · Swedish Orphan Biovitrum, Industry · Completed
Key facts
| NCT number | NCT00109031 |
|---|---|
| Title | Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) |
| Official title | A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation |
| Lead sponsor | Swedish Orphan Biovitrum, Industry |
| Collaborators | Amgen Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Cancer, Lymphoma, Leukemia |
| Intervention type | Drug, Radiation |
| Interventions | palifermin, Total Body Irradiation, Cyclophosphamide, Etoposide, Placebo |
| Enrollment | 47 |
| Start date | Jan 1, 2005 |
| Primary completion | Feb 1, 2006 |
| Completion | Dec 1, 2010 |
| First posted | Apr 25, 2005 |
| Last update posted | Sep 15, 2014 |
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: