Mouth Dissolving Mosapride Tables Enhance Post Cesarean G... | NCT03477266

Studies
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery

NCT03477266

Sponsor

Benha University

Status

Completed

Last Update Posted

Aug 14, 2018Actual

Enrollment

400Actual

Phase

Phase 3

Conditions

Prevention of Postoperative Ileus

Interventions

Mosapride
Placebo Oral Tablet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Aug 1, 2018Actual

First Submitted Date

Feb 21, 2018

First Submission Date that Met QC Criteria

Mar 23, 2018

First Posted Date

Mar 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2018

Last Update Posted Date

Aug 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Drug: Mosapride
Placebo mouth dissolving tablets	Placebo Comparator	Dummy identical tablets taken in the same way	Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mosapride	Drug	Intake mouthly dissolving mosapride tablets in immediate post cesarean section	Mouth dissolving mosapride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time of first flatus	Clinical	96 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
Paralytic ileus incidence and its severity	Clinical	7days
Toleration of fluids and solids intake	Clinical	2 weeks postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all women undergoing elective cesarean section

Exclusion Criteria:

prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

After cesarean section

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashraf N Elmantwe, MD	Benha University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ashraf nassif Elmantwe		Banhā	Elqalopia		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Once data collected and analyzed and published

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

When data became available and for ever

Access Criteria

Any

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062720	mosapride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

Color coded active tablets backed in red while identical dummy tablets coded in blue,both tablets are physically identical and usually no anticipated noticed side effects from mosapride

Who Masked

ParticipantCare ProviderOutcomes Assessor