Functioanl DyspepsiaPhase 2NCT00458328
The Effect of Z-338 in Subjects With Functional Dyspepsia
A Phase 2 study testing Z-338 in people with Functioanl Dyspepsia, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Functioanl Dyspepsia
- What is being tested?
- Z-338
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Jul 2010
- Phase
- Phase 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
- Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.
Who cannot join
- Subjects that heartburn should be the most bothersome symptom
- Subjects presenting with primary complaints relieved by stool movements (IBS)
- Subjects with diabetes by treatment
- Subjects that heartburn should be more than moderate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound
- Conditions
- Functioanl Dyspepsia
- Being tested
- Z-338
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-338Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functioanl DyspepsiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ken Haruma, MD, PhD, Study chair, Kawasaki Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458328
- Sponsor's protocol ID
- 99010208
- Status last verified
- Nov 2010
- First submitted
- 9 Apr 2007
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
- ClinicalTrials.gov ID
- NCT00458328
- Acronym / sponsor ID
- 99010208
- Conditions
- Functioanl Dyspepsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Apr 2007 (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.
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
- Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.
Key exclusion criteria (4 listed)
- Subjects that heartburn should be the most bothersome symptom
- Subjects presenting with primary complaints relieved by stool movements (IBS)
- Subjects with diabetes by treatment
- Subjects that heartburn should be more than moderate
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 |
|---|---|---|
| Z-338 | Drug | – |
Primary outcome
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
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 23 Nov 2010.
Related trials for Functioanl Dyspepsia
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Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
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Not yet recruitingPhase 4
Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
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Comparing Acotiamide and Itopride for the Management of Indigestion
Functioanl Dyspepsia, Post Prandial Distress Syndrome
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Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia
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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.
Ken Haruma, MD, PhD study chair
Kawasaki Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Z-338 in people with Functioanl Dyspepsia, run by Zeria Pharmaceutical at 1 site in Japan.
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 2 inclusion and 4 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 23 Nov 2010. 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 Japan. 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 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?
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index. 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 23 Nov 2010.