NauseaPhase 3NCT01984931
Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting
A Phase 3 study testing Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) and Metoclopramide hydrochloride monohydrate in people with Nausea and Vomiting, run by CM Chungmu Hospital at 1 site in South Korea.
Trial summary
This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia. Read more about this study
- Who is it for?
- Ages Up to 70 years
- What is being tested?
- Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) and Metoclopramide hydrochloride monohydrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2013
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI
Who cannot join
- above 70 years old
- massive rotator cuff tear
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chungmu General Hopsital
Seoul, Yeongdeungpo-gu, 150-034
Sang Hoon Lhee, MD, Phd, +82 (2) 2068/4525, cmirb@naver.com
Paolo Alan B Tabar, MD
About this study
Official title: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) as a Prophylactic Anti-emetic Drug for Patients Who Underwent Arthroscopic Rotator Cuff Repair: a Randomized Controlled Study
This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.
Read the detailed description
The patients will be divided in two groups using a computer generated randomization software. The first will be the MACPERAN group (controlled) and the other will be the NEWBUTIN group (variable). The controlled group will be treated with post-operative regimen in accordance with the standard protocol of the Chungmu Hospital, MACPERAN(Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A) thru IV twice in a day while the variable group will be given a single dose of NEWBUTIN SR 300 mg Tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
A clinical research coordinator will monitor the patient until 48 hours post-operative. First time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. All patients will be assessed using the simplified risk score of Apfel et al. to determine who have the risk factors for PONV. The episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. Nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. As retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. The efficacy of anti-emetic medication (NEWBUTIN 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and PONV (which was regarded as the primary outcome). The severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.Then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.
- Being tested
- Trimebutine Maleate (NEWBUTIN SR 300 mg Tab), Metoclopramide hydrochloride monohydrate
- Keywords
- post operative nausea and vomiting, Trimebutine Maleate
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)Drug
Also called •Antinime, •Cineprac, •Colixane B (Trimebutine and Bromazepam), •Colixane Prokin (Trimebutine and Mosapride)
Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
Metoclopramide hydrochloride monohydrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Trimebutine Maleate 300 mg Tab | Experimental | A single dose of NEWBUTIN SR 300 mg Tab will be given orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively. Receives: Drug: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) |
| Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A | Active comparator | Anti-emetic medication protocol of Chungmu Hospital includes MACPERAN (Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A)thru IV twice in a day Receives: Drug: Metoclopramide hydrochloride monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of nausea after taking Trimebutine Maleate as a prophylactic medication
The severity of nausea will be graded on a four-point scale. 0- no nausea (can do all tasks). 1- mild nausea (can talk and answer questions appropriately,sit, stand but can't walk). 2- moderate nausea (can talk and but answer questions inappropriately, sit but can't stand and walk). 3- severe nausea (don't talk and answer questions, prefers lying down, cannot sit, stand and walk).
Measured: 0-48 hours post rotator cuff repair
Secondary outcomes (1)
Frequency of PONV after taking Trimebutine Maleate as a prophylactic medication
Frequency is how often the patient experienced the episodes of nausea and vomiting in a given time period.
Measured: 0-48 hours post rotator cuff repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CM Chungmu Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea United Pharm. Inc.
- Responsible party
- Principal investigator, Sang-Hoon Lhee, CM Chungmu Hospital
- Investigators
- Paolo Alan B Tabar, MD, Principal investigator, International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984931
- Sponsor's protocol ID
- CMH-2013-02
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) as a Prophylactic Anti-emetic Drug for Patients Who Underwent Arthroscopic Rotator Cuff Repair: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01984931
- Acronym / sponsor ID
- CMH-2013-02
- Keywords
- post operative nausea and vomiting, Trimebutine Maleate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- CM Chungmu HospitalUniversity, hospital or other
- Collaborators
- Korea United Pharm. Inc.
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Nov 2013 (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 will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.
Detailed description
The patients will be divided in two groups using a computer generated randomization software. The first will be the MACPERAN group (controlled) and the other will be the NEWBUTIN group (variable). The controlled group will be treated with post-operative regimen in accordance with the standard protocol of the Chungmu Hospital, MACPERAN(Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A) thru IV twice in a day while the variable group will be given a single dose of NEWBUTIN SR 300 mg Tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
A clinical research coordinator will monitor the patient until 48 hours post-operative. First time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. All patients will be assessed using the simplified risk score of Apfel et al. to determine who have the risk factors for PONV. The episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. Nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. As retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. The efficacy of anti-emetic medication (NEWBUTIN 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and PONV (which was regarded as the primary outcome). The severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.Then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimebutine Maleate 300 mg Tab | Experimental | Drug: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)A single dose of NEWBUTIN SR 300 mg Tab will be given orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively. |
| Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A | Active comparator | Drug: Metoclopramide hydrochloride monohydrateAnti-emetic medication protocol of Chungmu Hospital includes MACPERAN (Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A)thru IV twice in a day |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI
Key exclusion criteria (2 listed)
- above 70 years old
- massive rotator cuff tear
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 |
|---|---|---|
| Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)Also: •Antinime, •Cineprac, •Colixane B (Trimebutine and Bromazepam), •Colixane Prokin (Trimebutine and Mosapride)Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively. | Drug | Trimebutine Maleate 300 mg Tab |
| Metoclopramide hydrochloride monohydrate | Drug | Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A |
Primary outcome
Severity of nausea after taking Trimebutine Maleate as a prophylactic medication
Time frame: 0-48 hours post rotator cuff repair
The severity of nausea will be graded on a four-point scale. 0- no nausea (can do all tasks). 1- mild nausea (can talk and answer questions appropriately,sit, stand but can't walk). 2- moderate nausea (can talk and but answer questions inappropriately, sit but can't stand and walk). 3- severe nausea (don't talk and answer questions, prefers lying down, cannot sit, stand and walk).
1 secondary outcome
Frequency of PONV after taking Trimebutine Maleate as a prophylactic medication
Time frame: 0-48 hours post rotator cuff repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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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.
Paolo Alan B Tabar, MD principal investigator
International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) and Metoclopramide hydrochloride monohydrate in people with Nausea and Vomiting, run by CM Chungmu 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Hoon Lhee, MD, PhD (+82 (2) 2068/4525, cmirb@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of nausea after taking Trimebutine Maleate as a prophylactic medication (time frame: 0-48 hours post rotator cuff repair). 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 15 Nov 2013.