Laparoscopic Gynecologic, Abdominal, Other SurgeryPhase 3NCT01568268

Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

A Phase 3 study testing Palonosetron in people with Laparoscopic Gynecologic, Abdominal, Other Surgery and General Anesthesia, run by Samsung Medical Center at 4 sites 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 study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia. Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia
What is being tested?: Palonosetron
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 384 participants
Where: 4 sitesSouth Korea
Study dates: Jan 2012to Jun 2012
Phase: Phase 3
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 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

19 years and older, younger than 70 years old
American society of Anesthesiologists physical status classification I to III
those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia
surgery for which anesthesia is expected to last at least 30 minutes
if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.

Who cannot join

known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient
inability to understand or cooperate with the study procedures as determined by the investigator
women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1.
has received any investigational drug within 30 days before study entry
having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.
any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia
known or suspected current history of alcohol abuse or drug abuse.
any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

Samsung Medical Center
Seoul, Seoul, 135-710
Bungdang Seoul National University Hospital
Seoul
Kangpook Samsung Hospital
Seoul
Sangye Bahk Hospital, Inje School of Medicine
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Read the detailed description

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Conditions: Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia
Being tested: Palonosetron, placebo control group
Keywords: palonosetron, postoperative nausea and vomiting
Medical subject headings: Postoperative Nausea and Vomiting

What participants receive

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

PalonosetronDrug
Also called Aloxi (palonosetron)
palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
placebo control groupDrug
Also called placebo
placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.

Study groups in NCT01568268
Study group	Role	What they receive
Palonsetron	Experimental	Not described Receives: Drug: Palonosetron
Placebo	Placebo comparator	Not described Receives: Drug: placebo control group

What is being measured

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

Complete response at 24 hr
Complete response means no retching or vomiting and no administration of secondary rescue drug.
Measured: at 24 hour after randomization

Secondary outcomes (8)

Complete response at 72 hr
Complete response means no retching or vomiting and no administration of secondary rescue drug.
Measured: at 72 hour after randomization
Complete control at 72 hr
Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.
Measured: at 72 hour after randomization
Complete control at 24 hr
Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.
Measured: at 24 hour after randomization
the incidence of nausea, retching, vomiting
the incidence of nausea with numerical rating scale >= 4, retching, vomiting
Measured: at 24, 48, 72 hr after randomization
Time to recovery of nausea, retching, or vomiting
Time to recovery of nausea, retching, or vomiting from administration of palonosetron
Measured: at 24, 48, 72 hr after randomization
the severity of nausea
the severity of nausea measured by NRS (numerical rating scale)
Measured: at the time of, 24, 48, 72 hour after randomization
the incidence of rescue drug use
the incidence of rescue drug use
Measured: at 24, 48, 72 hour after randomization
QOL by modified Osoba Nausea and Emesis Module
QOL by modified Osoba Nausea and Emesis Module
Measured: at 24, 48, 72 hour after randomization

Timeline

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

Jan 2012Jun 2012

First posted2 Apr 2012 (estimated)
Study startJan 2012
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Laparoscopic Gynecologic, Abdominal, Other SurgeryStudies of the same condition, open and under way.
More trials run by Samsung Medical CenterThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 384 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01568268
Sponsor's protocol ID: 2011-11-112
Other IDs: CJ_ALX_302
Status last verified: Dec 2013
First submitted: 29 Mar 2012
Last updated: 25 Dec 2013
Results posted: No
Data monitoring committee: Yes

Publications

Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19.
PubMed 25037960

Study at a glance

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

Official title: A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
ClinicalTrials.gov ID: NCT01568268
Acronym / sponsor ID: 2011-11-112
Conditions: Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia
Keywords: palonosetron, postoperative nausea and vomiting
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 384 participants (actual)
Lead sponsor: Samsung Medical CenterUniversity, hospital or other
Collaborators: HK inno.N Corporation
Study start: Jan 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 2 Apr 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 study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Palonsetron	Experimental	Drug: Palonosetron
Placebo	Placebo comparator	Drug: placebo control group

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

19 years and older, younger than 70 years old
American society of Anesthesiologists physical status classification I to III
those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia
surgery for which anesthesia is expected to last at least 30 minutes
if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.

Key exclusion criteria (8 listed)

known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient
inability to understand or cooperate with the study procedures as determined by the investigator
women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1.
has received any investigational drug within 30 days before study entry
having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.

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
PalonosetronAlso: Aloxi (palonosetron)palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.	Drug	Palonsetron
placebo control groupAlso: placeboplacebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.	Drug	Placebo

Primary outcome

Complete response at 24 hr
Time frame: at 24 hour after randomization
Complete response means no retching or vomiting and no administration of secondary rescue drug.

8 secondary outcomes

Complete response at 72 hr
Time frame: at 72 hour after randomization
Complete control at 72 hr
Time frame: at 72 hour after randomization
Complete control at 24 hr
Time frame: at 24 hour after randomization
the incidence of nausea, retching, vomiting
Time frame: at 24, 48, 72 hr after randomization
Time to recovery of nausea, retching, or vomiting
Time frame: at 24, 48, 72 hr after randomization
the severity of nausea
Time frame: at the time of, 24, 48, 72 hour after randomization
the incidence of rescue drug use
Time frame: at 24, 48, 72 hour after randomization
QOL by modified Osoba Nausea and Emesis Module
Time frame: at 24, 48, 72 hour after randomization

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 Dec 2013.
Derived from this study: PubMed 25037960Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19.

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.

Tae Soo Hahm, MD, PhD study director

Samsung Seoul Hospital, Samsung Medical Center

Youn Hong Kim, MD, PhD principal investigator

Kangpook Samsung Hospital, Samsung Medical Center

Jung Won Hwang, MD, PhD principal investigator

Seoul National University Bundang Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palonosetron in people with Laparoscopic Gynecologic, Abdominal, Other Surgery and General Anesthesia, run by Samsung Medical Center at 4 sites 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 8 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Complete response at 24 hr (time frame: at 24 hour after randomization). 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 NCT01568268, which also lists 1 linked publication.

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 Dec 2013.