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

Phase 2

Completed

• Conditions: Radiotherapy-induced Nausea and Vomiting (RINV)
• Interventions: Drug: SyB D-0701; Drug: Placebo

• Registration Number: NCT01700140
• Lead Sponsor: SymBio Pharmaceuticals

Brief 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)

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-09-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Results First Submitted: 2014-10-01
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-11
• Last Update Submitted: 2014-11-11
• Results First Posted: 2014-11-19
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SyB D-0701: high dose group	SyB D-0701	-
SyB D-0701: low dose group	SyB D-0701	-
placebo group	Placebo	-
SyB D-0701: low dose group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation	72 hours	The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.

Secondary Outcome Measures

Name	Time	Method
Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation	72 hours	The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
Time to First Emesis	24-72 hours	Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.
Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3	24-72 hours	Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.; The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.
Severe (Grade 3 or More) Adverse Events	Up to 192 hours	The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.; Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE
Adverse Events	Up to 192 hours	Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.
Skin Manifestations at Study Drug Application Site	Up to 192 hours	The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.; Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).
Time to First Nausea	24-72 hours	Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.
Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3	24-72 hours	Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.; The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.

Trial Locations

Locations (4)

Research Site; 🇯🇵 Koshigaya, Saitama, Japan

Research; 🇯🇵 Kyoto, Japan

Reseach site; 🇯🇵 Tokyo, Japan

Research site; 🇯🇵 Yamagata, Japan