Foreign Body Left During Endoscopic ExaminationPhase 3SMWNCT01284764
Efficacy Study of a Low Volume of Water Intake and Mosapride for Endoscopy in Patients With Subtotal Gastrectomy
A Phase 3 study testing Mosapride in people with Foreign Body Left During Endoscopic Examination, run by Inje University at 1 site in South Korea.
Trial summary
A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foreign Body Left During Endoscopic Examination
- What is being tested?
- Mosapride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Sep 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who had subtotal gastrectomy for gastric cancer
Who cannot join
- Pregnancy
- Lactation
- History of anastomotic stricture
- Recurrent advanced gastric cancer
- Poor general condition( > 2 ECOG)
- Other disseminated malignancy
- Significant renal failure or congestive heart failure (CHF)
- Liver failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Paik Hospital, Inje University School of Medicine
Busan, 612-030
About this study
Official title: Efficacy of a Low Volume of Water Intake and Mosapride for Endoscopy Preparation in Gastric Cancer Patients With Subtotal Gastrectomy: A Randomized Controlled Trial
A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.
Read the detailed description
We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. We plan to compare this method with routine midnight fasting method for endoscopy in patients with subtotal gastrectomy.
- Being tested
- Mosapride
- Keywords
- Endoscopy, Gastrectomy, Stomach neoplasms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaprideDrug
Also called Gasmotin
Mosapride 10mg, one dosage, once evening of the day before the endoscopy
| Study group | Role | What they receive |
|---|---|---|
| midnight fasting | No intervention | The patients in this group will have midnight fasting the day before endoscopic examination |
| Mosapride, low volume of water | Active comparator | The patients in this group will take mosapride and a 500mL water at evening of the day before endoscopic examination. Receives: Drug: Mosapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of food residue using endoscopic scoring system
We plan to evaluate how much a low volume of water and mosapride, compared with routine fasting, reduse food residue in gastric remnant for endoscopy.
Measured: six months
Secondary outcomes (1)
Tolerability of a low volume of water and mosapride
We plan to evaluate tolerability of a low volume of water and mosapride compared with routine fasting for endoscopy preparation in patients with subtotal gastrectomy
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body Left During Endoscopic ExaminationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, Inje University
- Investigators
- Eun Hee Seo, M.D., Principal investigator, Haeundae Paik HospitalTae Oh Kim, Ph.D., Study director, Haeundae Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284764
- Sponsor's protocol ID
- HGI-2011-01
- Acronym
- SMW
- Status last verified
- Oct 2011
- First submitted
- 26 Jan 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low Volume of Water Intake and Mosapride for Endoscopy Preparation in Gastric Cancer Patients With Subtotal Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01284764
- Acronym / sponsor ID
- SMW / HGI-2011-01
- Keywords
- Endoscopy, Gastrectomy, Stomach neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jan 2011 (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.
A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.
Detailed description
We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. We plan to compare this method with routine midnight fasting method for endoscopy in patients with subtotal gastrectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midnight fasting | No intervention | –The patients in this group will have midnight fasting the day before endoscopic examination |
| Mosapride, low volume of water | Active comparator | Drug: MosaprideThe patients in this group will take mosapride and a 500mL water at evening of the day before endoscopic examination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients who had subtotal gastrectomy for gastric cancer
Key exclusion criteria (8 listed)
- Pregnancy
- Lactation
- History of anastomotic stricture
- Recurrent advanced gastric cancer
- Poor general condition( > 2 ECOG)
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 |
|---|---|---|
| MosaprideAlso: GasmotinMosapride 10mg, one dosage, once evening of the day before the endoscopy | Drug | Mosapride, low volume of water |
Primary outcome
Degrees of food residue using endoscopic scoring system
Time frame: six months
We plan to evaluate how much a low volume of water and mosapride, compared with routine fasting, reduse food residue in gastric remnant for endoscopy.
1 secondary outcome
Tolerability of a low volume of water and mosapride
Time frame: six months
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 5 Oct 2011.
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.
Eun Hee Seo, M.D. principal investigator
Haeundae Paik Hospital
Tae Oh Kim, Ph.D. study director
Haeundae Paik 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 Mosapride in people with Foreign Body Left During Endoscopic Examination, run by Inje University 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 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 5 Oct 2011. 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?
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?
Degrees of food residue using endoscopic scoring system (time frame: six months). 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 5 Oct 2011.