CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 189 enrolled
Drug / intervention
SyB D-0701 +1 moredrug
Likely dose
SyB D-0701 18.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01700140
NCT01700140Phase 2Completed
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Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting

SymBio Pharmaceuticals·interventional·Posted Oct 4, 2012·Updated Nov 19, 2014

In Brief

A Phase 2 clinical trial evaluating SyB D-0701 and Placebo for Radiotherapy-induced Nausea and Vomiting (RINV). Completed, enrolled 189 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRadiotherapy-induced Nausea and Vomiting (RINV)
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 4, 2012
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.7 years ago

Interventions

SyB D-0701drug

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.

Placebodrug

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.