Prevention of Postoperative IleusPhase 3NCT03477266
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
A Phase 3 study testing Mosapride in people with Prevention of Postoperative Ileus, run by Benha University at 1 site in Egypt.
Trial summary
Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prevention of Postoperative Ileus
- What is being tested?
- Mosapride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Aug 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all women undergoing elective cesarean section
Who cannot join
- prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions
Read the detailed description
Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay
- Conditions
- Prevention of Postoperative Ileus
- Being tested
- Mosapride, Placebo Oral Tablet
- Keywords
- Postoperative ileus, mosapride, mouth dissolving tablets, Intraoperative vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaprideDrug
Also called Fluxopride
Intake mouthly dissolving mosapride tablets in immediate post cesarean section
Placebo Oral TabletDrug
Also called Placebo
Dummy identical tablets to mouthly dissolving mosapride tablets
| Study group | Role | What they receive |
|---|---|---|
| Mouth dissolving mosapride | Experimental | Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days Receives: Drug: Mosapride |
| Placebo mouth dissolving tablets | Placebo comparator | Dummy identical tablets taken in the same way Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first flatus
Clinical
Measured: 96 hours postoperative
Secondary outcomes (4)
Paralytic ileus incidence and its severity
Clinical
Measured: 7days
Toleration of fluids and solids intake
Clinical
Measured: 2 weeks postoperative
Incidence of intraoperative and postoperative nausea and vomiting
Clinical
Measured: Intraoperative and 2 weeks postoperative
First defecation
Clinical
Measured: 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashraf nassif mahmoud elmantwe,MD, Benha University
- Investigators
- Ashraf N Elmantwe, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477266
- Sponsor's protocol ID
- Ashrafnassif2002@yahoo.com
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data collected and analyzed and published
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03477266
- Acronym / sponsor ID
- Ashrafnassif2002@yahoo.com
- Conditions
- Prevention of Postoperative Ileus
- Keywords
- Postoperative ileus, mosapride, mouth dissolving tablets, Intraoperative vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 26 Mar 2018 (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.
Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions
Detailed description
Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouth dissolving mosapride | Experimental | Drug: MosaprideFluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days |
| Placebo mouth dissolving tablets | Placebo comparator | Drug: Placebo Oral TabletDummy identical tablets taken in the same way |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all women undergoing elective cesarean section
Key exclusion criteria (1 listed)
- prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride
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: FluxoprideIntake mouthly dissolving mosapride tablets in immediate post cesarean section | Drug | Mouth dissolving mosapride |
| Placebo Oral TabletAlso: PlaceboDummy identical tablets to mouthly dissolving mosapride tablets | Drug | Placebo mouth dissolving tablets |
Primary outcome
Time of first flatus
Time frame: 96 hours postoperative
Clinical
4 secondary outcomes
Paralytic ileus incidence and its severity
Time frame: 7days
Toleration of fluids and solids intake
Time frame: 2 weeks postoperative
Incidence of intraoperative and postoperative nausea and vomiting
Time frame: Intraoperative and 2 weeks postoperative
First defecation
Time frame: 2 weeks postoperative
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 14 Aug 2018.
- Individual participant dataSharing planned: Yes. Once data collected and analyzed and published
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Postoperative Ileus
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.
Ashraf N Elmantwe, MD principal investigator
Benha University
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 Prevention of Postoperative Ileus, run by Benha University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 14 Aug 2018. 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 Egypt. 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?
Time of first flatus (time frame: 96 hours postoperative). 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 14 Aug 2018.