NCT00540696 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cella D, Viswanathan HN, Hays RD, Mendoza TR, Stein KD, Pasta DJ, Foreman AJ, Vadhan-Raj S, Kallich JD
Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy. Cancer. 2008 Sep 15;113(6):1480-8. doi: 10.1002/
Kallich J, McDermott A, Xu X, Fayers P, Cella D
The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006 Feb;15(1):57-68.
Vadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, McGuire WP
Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol. 2003 Jul-Aug;1(2):131-8

An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)

Details for clinical trial NCT00540696

Clinical trial NCT00540696 - References