Healthy VolunteersPhase 1/2NCT01669772
Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers
A Phase 1/2 study of Healthy Volunteers, run by Myung-gui Choi at 1 site in South Korea.
Trial summary
DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 1/2
- 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
- Healthy adults of either sex, at least 20 years of age
- Having no abdominal discomfort or pain
- No diseases diagnosed by screening gastroduodenoscopy
- Having given voluntary written consent
Who cannot join
- Currently participating or having participated in another drug trial within four weeks of trial start.
- Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
- A history of surgery which may affect gastrointestinal motility.
- Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
- Subjects with irritable bowel syndrome or inflammatory bowel disease.
- Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system.
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- Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.
- Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks.
- Other reasons that the investigator considers valid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects
DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.
- Conditions
- Healthy Volunteers
- Being tested
- DA-9701 and placebo, Placebo and DA-9701
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9701 and placeboDrug
Also called DA-9701(motilitone)
Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.
Placebo and DA-9701Drug
Also called DA-9701(motilitone)
Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| DA-9701 and placebo | Other | Administer DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again. Receives: Drug: DA-9701 and placebo |
| Placebo and DA-9701 | Other | Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again. Receives: Drug: Placebo and DA-9701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effects of DA-9701 on GI motility in healthy adult volunteers
Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers
Measured: 3weeks
Secondary outcomes (3)
Examine the effects of DA-9701 by Scintigraphic transit measurement
Examine the effects of DA-9701 by Scintigraphic transit measurement
Measured: 3weeks
Examine the effects of DA-9701 by EGG/Drink test
Examine the effects of DA-9701 by EGG/Drink test
Measured: 3weeks
Examine the effects of DA-9701 by SPECT
Examine the effects of DA-9701 by SPECT
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myung-gui Choi
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Myung-gui Choi, The Catholic University of Korea
- Investigators
- Myong Ki Baeg, MD, Principal investigator, CU Korea, Seoul St Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669772
- Sponsor's protocol ID
- DA-9701 trial
- Status last verified
- Jul 2014
- First submitted
- 12 Aug 2012
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects
- ClinicalTrials.gov ID
- NCT01669772
- Acronym / sponsor ID
- DA-9701 trial
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Myung-gui ChoiUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Aug 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.
DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-9701 and placebo | Other | Drug: DA-9701 and placeboAdminister DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again. |
| Placebo and DA-9701 | Other | Drug: Placebo and DA-9701Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults of either sex, at least 20 years of age
- Having no abdominal discomfort or pain
- No diseases diagnosed by screening gastroduodenoscopy
- Having given voluntary written consent
Key exclusion criteria (9 listed)
- Currently participating or having participated in another drug trial within four weeks of trial start.
- Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
- A history of surgery which may affect gastrointestinal motility.
- Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
- Subjects with irritable bowel syndrome or inflammatory bowel disease.
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 |
|---|---|---|
| DA-9701 and placeboAlso: DA-9701(motilitone)Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo. | Drug | DA-9701 and placebo |
| Placebo and DA-9701Also: DA-9701(motilitone)Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week. | Drug | Placebo and DA-9701 |
Primary outcome
Study the effects of DA-9701 on GI motility in healthy adult volunteers
Time frame: 3weeks
Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers
3 secondary outcomes
Examine the effects of DA-9701 by Scintigraphic transit measurement
Time frame: 3weeks
Examine the effects of DA-9701 by EGG/Drink test
Time frame: 3weeks
Examine the effects of DA-9701 by SPECT
Time frame: 3weeks
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 3 Jul 2014.
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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.
Myong Ki Baeg, MD principal investigator
CU Korea, Seoul 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 1/2 study of Healthy Volunteers, run by Myung-gui Choi 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 4 inclusion and 9 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 3 Jul 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Study the effects of DA-9701 on GI motility in healthy adult volunteers (time frame: 3weeks). 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 3 Jul 2014.