Stomach CancerNCT04493125
Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy
A study testing Mosapride citrate in people with Stomach Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stomach Cancer
- What is being tested?
- Mosapride citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2020to 30 Mar 2021
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with gastric cancer pathologically before surgery
- Patients who underwent surgical resection (R0 resection)
- Patients with an ASA score of 3 or less
Who cannot join
- Patients over 80 years old
- When there are multiple or peritoneal metastases
- Intestinal obstruction before surgery
- When chemotherapy was performed before surgery
- When cancer other than stomach cancer is diagnosed
- If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy
- In case of liver failure or kidney failure
- When it is judged that uncontrolled diabetes may affect intestinal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy: Prospective, Double Blind Placebo-controlled Study
"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.
Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.
To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."
- Conditions
- Stomach Cancer
- Being tested
- Mosapride citrate, Placebo
- Keywords
- Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus
- Medical subject headings
- Stomach Neoplasms, Tissue Adhesions, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosapride citrateDrug
Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mosapride group | Experimental | Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery. Receives: Drug: Mosapride citrate |
| Placebo group | Placebo comparator | Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of radiopaque markers transferred to the large intestine 3 days after surgery
Intestinal motility after gastrectomy
Measured: 3 Days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start27 Jul 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493125
- Sponsor's protocol ID
- 3-2020-0175
- Status last verified
- Jan 2025
- First submitted
- 28 Jul 2020
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy: Prospective, Double Blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04493125
- Acronym / sponsor ID
- 3-2020-0175
- Conditions
- Stomach Cancer
- Keywords
- Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 30 Jul 2020 (actual)
- 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.
"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.
Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.
To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mosapride group | Experimental | Drug: Mosapride citratePatients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with gastric cancer pathologically before surgery
- Patients who underwent surgical resection (R0 resection)
- Patients with an ASA score of 3 or less
Key exclusion criteria (8 listed)
- Patients over 80 years old
- When there are multiple or peritoneal metastases
- Intestinal obstruction before surgery
- When chemotherapy was performed before surgery
- When cancer other than stomach cancer is diagnosed
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 |
|---|---|---|
| Mosapride citratePatients receive mosapride citrate (5mg/T) three times a day from the first day after surgery. | Drug | Mosapride group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
The number of radiopaque markers transferred to the large intestine 3 days after surgery
Time frame: 3 Days after surgery
Intestinal motility after gastrectomy
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 8 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mosapride citrate in people with Stomach Cancer, run by Gangnam Severance 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 3 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 8 Jan 2025. 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. 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.
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 number of radiopaque markers transferred to the large intestine 3 days after surgery (time frame: 3 Days after surgery). 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 Jan 2025.