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Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)

NCT01659775 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2013-07-25

No results posted yet for this study

Summary

This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.

The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR) of Chemotherapy Induced Nausea and Vomiting (CINV).

Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for 1-5 days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to HE chemotherapy).

* Sancuso patch
* Zofran inj. + Zofran tab.

The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient will be assessed daily until 5days after first chemotherapy administration. Adverse Events (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be followed-up until 2 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.

Conditions

  • Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)

Interventions

DRUG

Sancuso patch

Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24hours) prior to start of chemotherapy.

DRUG

Zofran inj.+Zofran tab.

Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days. Active Comparator arm: administered intravenously (24mg or 32mg) on Day 1 of chemotherapy and orally (8mg bid) on Day 2-5.

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Principal Investigators

  • Jin-Hyoung Kang, MD,PhD · Seoul St'. Mary's Hospital

  • Hoon-Kyo Kim, MD,PhD · St Vincent's Hospital

  • Suk-Young Park, MD,PhD · Daejeon St. Mary's hospital

  • Jong-Youl Jin, MD,PhD · Bucheon St. Mary's Hospital

  • In-Sook Woo, MD,PhD · Yeouido St. Mary's Hospital

  • Yoon-Ho Ko, MD,PhD · Uijeongbu St. Mary's Hospital

  • Der-Sheng Sun, MD,PhD · Cheongju St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659775 on ClinicalTrials.gov