NCT01662687

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

Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy. Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to ME chemotherapy). * Sancuso patch * Kytril inj.+Kytril tab. The patch will be applied 2days (48-24h) prior to first daily dose of the moderately emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until 14 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

Type	Name	Description
DRUG	Sancuso patch	Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy.
DRUG	Kytril inj.+Kytril tab.	Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Active Comparator arm: * Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1). * Kytril tab. 1mg: administered twice a day by orally at Day 2\~4.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-08-10
• Last updated: 2012-08-17

Locations

1 site across 1 country: South Korea