Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)Phase 4NCT01659775

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)

A Phase 4 study testing Sancuso patch and Zofran inj.+Zofran tab. in people with Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV), run by LG Life Sciences at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
What is being tested?: Sancuso patch and Zofran inj.+Zofran tab.
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 389 participants
Where: 1 siteSouth Korea
Study dates: Aug 2011to Nov 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged over 20 yrs
Eastern Cooperative Oncology Group performance status 0, 1, 2
Life expectancy of ≥ 3 months
Assigned to receive a cycle of high emetic (HE) chemotherapy regimen including the daily administration of a cytotoxic regimen with the emetogenic potential of level 5 (Hesketh Classification)
Patients who signed the informed consent form

Who cannot join

Previous History
Hypersensitivity to adhesive plasters
Contraindications to 5-HT3 receptor antagonists
Any other relevant medical history (at the discretion of the investigator)
Concomitant Medical Condition
Current alcohol, drug or medication abuse

Show all 23Show fewer

Currently pregnant or breast feeding women, including planning pregnancy
Clinically relevant abnormal laboratory values (at the discretion of the investigator)
Clinically relevant hepatic, renal, infectious, neurological or psychiatric disorders, or any other major systemic illness (at the discretion of the investigator)
Any cause for nausea and vomiting other than CINV
Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to the chemotherapy administration
Clinically relevant abnormal ECG parameters at the discretion of the investigator
Concomitant Therapy/Medication
Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
Intake of medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder or neuropathy (unless peripheral neuropathy at the discretion of the investigator)
Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a stable dose for the duration of the study)
Receipt of a narcotic analgesics (acceptable at the discretion of the investigator)
Receipt of any other investigational drug < 30 days before the study start or during the study
Scheduled to receive a neurokinin NK1 receptor antagonist, dopamine receptor antagonist or another 5-HT3 receptor antagonist at 72 h prior to the administration of the chemotherapy or scheduled to do those medication after patch removal
Drugs known to increase the QTc interval (unless a stable dose for the duration of the study at the discretion of the investigator)
Other
Patients unlikely to comply with the study protocol (at the discretion of the investigator), e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
The patch adhesion level was not more than 50% on the day of chemotherapy or the patch was not attached within two days before the chemotherapy

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul St. Mary's Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Open-label, Paralleled-group, Active-controlled, Phase IV Study to Evaluate the Efficacy and Safety of Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic (HE) Chemotherapy

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)
Being tested: Sancuso patch, Zofran inj.+Zofran tab.
Medical subject headings: Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sancuso patchDrug
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.
Zofran inj.+Zofran tab.Drug
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.

Study groups in NCT01659775
Study group	Role	What they receive
Sancuso patch	Experimental	Not described Receives: Drug: Sancuso patch
Zofran	Active comparator	Not described Receives: Drug: Zofran inj.+Zofran tab.

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage of patients achieving Compete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen

Secondary outcomes (12)

The percentage of patients achieving Complete Response (CR)
Measured: overall (Day 1~5)
The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
The percentage of patients achieving Compete Control (CC)
Measured: overall (Day 1~5)
severity of nausea
Measured: overall (Day 1~5)
severity of vomiting
Measured: overall (Day 1~5)
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Patient's satisfaction with anti-emetic therapy
The overall response to anti-emetic therapy was assessed and recorded by patients at Visit 8. The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines.
Measured: overall (Day 1~5)
The percentage of patients achieving Complete Response (CR)
Measured: per day (Day1, 2, 3, 4, 5)
The percentage of patients achieving Compete Control (CC)
Measured: per day (Day 1, 2, 3, 4, 5)
severity of nausea
Measured: per day (Day 1, 2, 3, 4, 5)
severity of vomiting
Measured: per day (Day 1, 2, 3, 4, 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Nov 2012

First posted8 Aug 2012 (estimated)
Study startAug 2011
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01659775
Sponsor's protocol ID: LG-SCSCL001
Status last verified: Jan 2012
First submitted: 27 Jul 2012
Last updated: 25 Jul 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label, Paralleled-group, Active-controlled, Phase IV Study to Evaluate the Efficacy and Safety of Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic (HE) Chemotherapy
ClinicalTrials.gov ID: NCT01659775
Acronym / sponsor ID: LG-SCSCL001
Conditions: Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: LG Life SciencesIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 8 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Sancuso patch
Zofran inj. + Zofran tab.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sancuso patch	Experimental	Drug: Sancuso patch
Zofran	Active comparator	Drug: Zofran inj.+Zofran tab.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female aged over 20 yrs
Eastern Cooperative Oncology Group performance status 0, 1, 2
Life expectancy of ≥ 3 months
Assigned to receive a cycle of high emetic (HE) chemotherapy regimen including the daily administration of a cytotoxic regimen with the emetogenic potential of level 5 (Hesketh Classification)
Patients who signed the informed consent form

Key exclusion criteria (23 listed)

Previous History
Hypersensitivity to adhesive plasters
Contraindications to 5-HT3 receptor antagonists
Any other relevant medical history (at the discretion of the investigator)
Concomitant Medical Condition

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sancuso patchEligible 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	Sancuso patch
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.	Drug	Zofran

Primary outcome

The percentage of patients achieving Compete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen

12 secondary outcomes

The percentage of patients achieving Complete Response (CR)
Time frame: overall (Day 1~5)
The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
The percentage of patients achieving Compete Control (CC)
Time frame: overall (Day 1~5)
severity of nausea
Time frame: overall (Day 1~5)
severity of vomiting
Time frame: overall (Day 1~5)
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Patient's satisfaction with anti-emetic therapy
Time frame: overall (Day 1~5)
The percentage of patients achieving Complete Response (CR)
Time frame: per day (Day1, 2, 3, 4, 5)
The percentage of patients achieving Compete Control (CC)
Time frame: per day (Day 1, 2, 3, 4, 5)
severity of nausea
Time frame: per day (Day 1, 2, 3, 4, 5)
severity of vomiting
Time frame: per day (Day 1, 2, 3, 4, 5)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jin-Hyoung Kang, MD,PhD principal investigator

Seoul St'. Mary's Hospital

Hoon-Kyo Kim, MD,PhD principal investigator

St Vincent's Hospital

Suk-Young Park, MD,PhD principal investigator

Daejeon St. Mary's hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sancuso patch and Zofran inj.+Zofran tab. in people with Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV), run by LG Life Sciences at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients achieving Compete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen (time frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01659775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.