NCT02437825 - 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)

Agra IM, Carvalho AL, Pontes E, Campos OD, Ulbrich FS, Magrin J, Kowalski LP
Postoperative complications after en bloc salvage surgery for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2003 Dec;129(12):1317-21.
Bomeli SR, Desai SC, Johnson JT, Walvekar RR
Management of salivary flow in head and neck cancer patients--a systematic review. Oral Oncol. 2008 Nov;44(11):1000-8. doi: 10.1016/j.oraloncology.2008.02.007. Epub 2008 May 16. Review.
Gilbert MR, Sturm JJ, Gooding WE, Johnson JT, Kim S
Pectoralis major myofascial onlay and myocutaneous flaps and pharyngocutaneous fistula in salvage laryngectomy. Laryngoscope. 2014 Dec;124(12):2680-6. doi: 10.1002/lary.24796. Epub 2014 Jul 30.
Loguercio C, de Sio I, Romano M, del Vecchio Blanco C, Coltorti M
Effect of somatostatin on salivary secretion in man. Digestion. 1987;36(2):91-5.
Spinell C, Ricci E, Berti P, Miccoli P
Postoperative salivary fistula: therapeutic action of octreotide. Surgery. 1995 Jan;117(1):117-8.
Victora CG, Huttly SR, Fuchs SC, Olinto MT
The role of conceptual frameworks in epidemiological analysis: a hierarchical approach. Int J Epidemiol. 1997 Feb;26(1):224-7.

Prospective Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy of Octreotide in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery

Details for clinical trial NCT02437825

Clinical trial NCT02437825 - References