NCT01700140

Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

Detailed description

Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)

Conditions

• Radiotherapy-induced Nausea and Vomiting (RINV)

Interventions

Type	Name	Description
DRUG	SyB D-0701	Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
DRUG	Placebo	Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-10-04
• Last updated: 2014-11-19
• Results posted: 2014-11-19

Locations

21 sites across 1 country: Japan