NCT03407430 - 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)

Amgen
Pegfilgrastim. Package Insert. Accessed June 9, 2013
Kirshner J, Hickock J, Hofman M
Pegfilgrastim-induced bone pain: Incidence, risk factors, and management in a community practice. Comm Onc 4:455-459, 2007.
Kirshner JJ, Heckler CE, Janelsins MC, Dakhil SR, Hopkins JO, Coles C, Morrow GR
Prevention of pegfilgrastim-induced bone pain: a phase III double-blind placebo-controlled randomized clinical trial of the university of rochester cancer center clinical community oncology program research base. J Clin Oncol. 2012 Jun 1;30(16):1974-9. doi: 10.1200/JCO.2011.37.8364. Epub 2012 Apr 16.
Kubista E, Glaspy J, Holmes FA, Green MD, Hackett J, Neumann T; Pegfilgrastim Study Group
Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer. Clin Breast Cancer. 2003 Feb;3(6):391-8.
Tassone DM, Boyce E, Guyer J, Nuzum D
Pregabalin: a novel gamma-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders. Clin Ther. 2007 Jan;29(1):26-48. Review.

A Phase II, Placebo-controlled, Double-blind, Randomized Crossover Trial of Pregabalin for the Prophylaxis of Pegfilgrastim-induced Bone Pain

Clinical trial NCT03407430 - References