Facial Bones FracturePhase 4NCT01637545
Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
A Phase 4 study testing Ramosetron in people with Facial Bones Fracture, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Bones Fracture
- What is being tested?
- Ramosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient who sign informed consent form for the study
- patient who are considered as surgical candidates with facial bones fracture
Who cannot join
- Patient who have had nausea/vomiting episodes
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations
Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
Read the detailed description
- Participants
- 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
- Randomization
- G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
- G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
- G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
- The primary endpoint
- the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
- The secondary endpoints
- the severity of nausea, need for rescue medication
- patient satisfaction with efficacy
- Conditions
- Facial Bones Fracture
- Being tested
- Ramosetron
- Keywords
- facial bones, Post operative nasea vomiting, fractures, reduction
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Also called Nasea®
G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
G3 - No medication but regular antiemetics injection if the patient want
| Study group | Role | What they receive |
|---|---|---|
| Preop. ramosetron 0.3mg i.v. | Active comparator | G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery Receives: Drug: Ramosetron |
| Postop. ramosetron 0.3mg i.v. | Active comparator | G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room Receives: Drug: Ramosetron |
| No Ramosetron | Active comparator | G3 - No medication but regular antiemetics injection if the patient wants Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of nausea and vomiting
Measured: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
Secondary outcomes (1)
patient satisfaction with the effect
Measured: at 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Principal Investigator is away on business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Bones FractureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Yeong Heo, Seoul National University Hospital
- Investigators
- Chanyeong Heo, Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637545
- Sponsor's protocol ID
- B-1107-131-007
- Other IDs
- L-2011-329-1
- Status last verified
- May 2015
- First submitted
- 8 Jul 2012
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations
- ClinicalTrials.gov ID
- NCT01637545
- Acronym / sponsor ID
- B-1107-131-007
- Conditions
- Facial Bones Fracture
- Keywords
- facial bones, Post operative nasea vomiting, fractures, reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator is away on business
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Jul 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.
Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
Detailed description
- Participants
- 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
- Randomization
- G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
- G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
- G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
- The primary endpoint
- the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
- The secondary endpoints
- the severity of nausea, need for rescue medication
- patient satisfaction with efficacy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preop. ramosetron 0.3mg i.v. | Active comparator | Drug: RamosetronG1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery |
| Postop. ramosetron 0.3mg i.v. | Active comparator | Drug: RamosetronG2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room |
| No Ramosetron | Active comparator | Drug: RamosetronG3 - No medication but regular antiemetics injection if the patient wants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who sign informed consent form for the study
- patient who are considered as surgical candidates with facial bones fracture
Key exclusion criteria (1 listed)
- Patient who have had nausea/vomiting episodes
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 |
|---|---|---|
| RamosetronAlso: Nasea®G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3 - No medication but regular antiemetics injection if the patient want | Drug | No Ramosetron, Postop. ramosetron 0.3mg i.v., Preop. ramosetron 0.3mg i.v. |
Primary outcome
incidence and severity of nausea and vomiting
Time frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
1 secondary outcome
patient satisfaction with the effect
Time frame: at 24 h after surgery
Results and safety
The study was stopped early (reason given: Principal Investigator is away on business). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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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.
Chanyeong Heo, Ph.D. principal investigator
Seoul National University Bundang 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 Ramosetron in people with Facial Bones Fracture, run by Seoul National University Hospital 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 May 2015. 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 was stopped early (reason given: Principal Investigator is away on business). Results are not available in the source record.
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?
incidence and severity of nausea and vomiting (time frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2015.