Functional DyspepsiaPhase 3NCT03024086
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia
A Phase 3 study testing DWJ1252 and Gasmotin in people with Functional Dyspepsia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- DWJ1252 and Gasmotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2016to 25 Apr 2017
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male of female of at least 19 years old
- Patient with functional dyspepsia met the ROME III criteria
Who cannot join
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- Patients with history of gastrointestinal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.
- Conditions
- Functional Dyspepsia
- Being tested
- DWJ1252, Gasmotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1252Drug
DWJ1252 and Placebo of Gasmotin
GasmotinDrug
Gasmotin and Placebo of DWJ1252
| Study group | Role | What they receive |
|---|---|---|
| DWJ1252 | Experimental | DWJ1252 + Placebo of Gasmotin Receives: Drug: DWJ1252 |
| Gasmotin | Active comparator | Gasmotin + Placebo of DWJ1252 Receives: Drug: Gasmotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in GIS (Gastrointestinal Symptom Score)
Measured: At 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start12 Dec 2016
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024086
- Sponsor's protocol ID
- DW_DWJ1252002
- Status last verified
- Jun 2019
- First submitted
- 29 Dec 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)
- ClinicalTrials.gov ID
- NCT03024086
- Acronym / sponsor ID
- DW_DWJ1252002
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 18 Jan 2017 (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 evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1252 | Experimental | Drug: DWJ1252DWJ1252 + Placebo of Gasmotin |
| Gasmotin | Active comparator | Drug: GasmotinGasmotin + Placebo of DWJ1252 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male of female of at least 19 years old
- Patient with functional dyspepsia met the ROME III criteria
Key exclusion criteria (3 listed)
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- Patients with history of gastrointestinal cancer
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 |
|---|---|---|
| DWJ1252DWJ1252 and Placebo of Gasmotin | Drug | DWJ1252 |
| GasmotinGasmotin and Placebo of DWJ1252 | Drug | Gasmotin |
Primary outcome
The change from baseline in GIS (Gastrointestinal Symptom Score)
Time frame: At 4 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 26 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWJ1252 and Gasmotin in people with Functional Dyspepsia, run by Daewoong 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 2 inclusion and 3 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 26 Jun 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The change from baseline in GIS (Gastrointestinal Symptom Score) (time frame: At 4 Weeks). 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 26 Jun 2019.