NCT01719575

Brief Summary

The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

October 26, 2012

Last Update Submit

August 13, 2013

Conditions

Healthy Female and Male

Outcome Measures

Primary Outcomes (2)

  • gastric fuction of Motilitone

    gastric emptying time on day 4 by scintigraphic imaging

    3 weeks

  • gastric function of Motilitone

    fasting and postprandial gastric volume on day 7 by single photon emission computed tomography

    3 weeks

Secondary Outcomes (3)

  • adverse events of Motilitone

    3 weeks

  • small bowel function of Motilitone

    3 weeks

  • Colon function of Motilitone

    3 weeks

Study Arms (2)

Motilitone

OTHER

take motilitone 30mg three times daily for the first week After 7 day wash-out period, take placebo three times daily for the second week

Drug: Motilitone

Placebo

OTHER

take placebo three times daily for the first week After 7 day wash-out period, take motilitone 30mg three times daily for the second week

Drug: Placebo

Interventions

MotilitoneDRUG
Motilitone
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no gastrointestinal symptoms
  • no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
  • written informed consent

You may not qualify if:

  • pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
  • history of abdominal surgery that may influence gastrointestinal motility
  • gastrointestinal hemorrhage, mechanical ileus, enterobrosis
  • irritable bowel syndrome, inflammatory bowel disease
  • severe disturbance of liver, kidney, heart,lung,blood and endocrine
  • psychoneurosis, alcoholism, drug dependence
  • medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Catholic university of korea college of Medicine, Seoul St.Mary's hospital

Banpo-dong, Seocho-gu, Seoul, South Korea

Location

Study Officials

  • Myung-Gyu Choi, Ph.D.

    Seul St.Mary's hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 1, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

KR(1)