Completed
Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting
What is being tested
SyB D-0701
+ SyB D-0701
+ Placebo
Drug
Who is being recruted
Signs and Symptoms+1
+ Signs and Symptoms, Digestive
+ Pathological Conditions, Signs and Symptoms
Over 20 Years
+23 Eligibility Criteria
How is the trial designed
Placebo-ControlledPhase 2
Interventional
Study Start: May 2011
Summary
Principal SponsorSymBio Pharmaceuticals
Last updated: November 19, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)
Principal SponsorSymBio Pharmaceuticals
Last updated: November 19, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
189 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsVomiting
Criteria
9 inclusion criteria required to participate
Cancer patients scheduled for radiotherapy over a field of at least 100 cm2 (50 cm2 or more in cases of irradiation of the vertebrae only) that includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic cavity)
Female patients of child-bearing potential who agree to practice adequate contraception during the study
Male patients who are surgically sterilized, or who agree to practice adequate contraception during the study
Patients not scheduled to receive anti-tumor agents between the first and the fifth day of radiotherapy. If the patient has a history of anti-tumor agent therapy, however, at the time of the patient's registration, at least 5 days must have elapsed since drug administration was terminated, and the patient must not be scheduled to receive any anti-tumor agent from the first to the fifth day of radiotherapy
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14 exclusion criteria prevent from participating
Other patients judged as unsuitable by the investigator or sub-investigators
Patients who are pregnant, who might be pregnant or who are currently lactating
Patients who have participated in some type of clinical study (including physician-initiated clinical studies or clinical research) within 3 months prior to their registration for the present study and who have been given a study drug (including drugs not yet approved). Patients can be registered for this study, however, if they have participated in a clinical study, etc., in which only drugs already approved have been used
Patients who previously received radiotherapy to the brain or to the region that includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic cavity)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 21 locations
Research site
Kashiwa, JapanResearch site
Matsuyama, JapanResearch site
Kurume, JapanCompleted21 Study Centers