NCT01284764

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

January 26, 2011

Last Update Submit

October 4, 2011

Conditions

Foreign Body Left During Endoscopic Examination

Keywords

EndoscopyGastrectomyStomach neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (1)

  • Tolerability of a low volume of water and mosapride

    six months

Study Arms (2)

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.

Drug: Mosapride

Interventions

MosaprideDRUG

Mosapride 10mg, one dosage, once evening of the day before the endoscopy

Also known as: Gasmotin
Mosapride, low volume of water

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients who had subtotal gastrectomy for gastric cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital, Inje University School of Medicine

Busan, 612-030, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

mosapride

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Eun Hee Seo, M.D.

    Haeundae Paik Hospital

    PRINCIPAL INVESTIGATOR

  • Tae Oh Kim, Ph.D.

    Haeundae Paik Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
fellow

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

KR(1)