Healthy Female and MalePhase 4DA-9701NCT01719575
Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers
A Phase 4 study testing Motilitone in people with Healthy Female and Male, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Female and Male
- What is being tested?
- Motilitone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Nov 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
the Catholic university of korea college of Medicine, Seoul St.Mary's hospital
Banpo-dong, Seocho-gu, Seoul
About this study
Official title: A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers
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.
- Conditions
- Healthy Female and Male
- Being tested
- Motilitone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotilitoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric fuction of Motilitone
gastric emptying time on day 4 by scintigraphic imaging
Measured: 3 weeks
gastric function of Motilitone
fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
Measured: 3 weeks
Secondary outcomes (3)
adverse events of Motilitone
Measured: 3 weeks
small bowel function of Motilitone
small bowel transit time on day 4 by scintigraphic transit measurement
Measured: 3 weeks
Colon function of Motilitone
colon transit time on day 4 and 7 by KUB
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female and MaleStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Gyu Choi, Ph.D., Principal investigator, Seul St.Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719575
- Sponsor's protocol ID
- DA9701_GA_IV
- Acronym
- DA-9701
- Status last verified
- Aug 2013
- First submitted
- 26 Oct 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01719575
- Acronym / sponsor ID
- DA-9701 / DA9701_GA_IV
- Conditions
- Healthy Female and Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motilitone | Other | Drug: Motilitonetake motilitone 30mg three times daily for the first week After 7 day wash-out period, take placebo three times daily for the second week |
| Placebo | Other | Drug: Placebotake placebo three times daily for the first week After 7 day wash-out period, take motilitone 30mg three times daily for the second week |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Motilitone | Drug | Motilitone |
| Placebo | Drug | Placebo |
Primary outcome
gastric fuction of Motilitone
Time frame: 3 weeks
gastric emptying time on day 4 by scintigraphic imaging
gastric function of Motilitone
Time frame: 3 weeks
fasting and postprandial gastric volume on day 7 by single photon emission computed tomography
3 secondary outcomes
adverse events of Motilitone
Time frame: 3 weeks
small bowel function of Motilitone
Time frame: 3 weeks
Colon function of Motilitone
Time frame: 3 weeks
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 15 Aug 2013.
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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.
Myung-Gyu Choi, Ph.D. principal investigator
Seul St.Mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motilitone in people with Healthy Female and Male, run by Dong-A Pharmaceutical Co., Ltd. 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 7 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 15 Aug 2013. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
gastric fuction of Motilitone (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 15 Aug 2013.