DiarrheaPhase 1NCT05816681
Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.
A Phase 1 study testing DWJ1230 and DWB2001 in people with Diarrhea, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- DWJ1230 and DWB2001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2022to 10 Apr 2023
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
- Male or Female subjects aged between 19 and 60 years at screening.
- Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information.
Who cannot join
- No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
- Identified or strongly suspected organic cause to diarrhea.
- Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
- History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
- Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
- Known domestic, leisure or professional exposure to elemental impurities.
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- Women who are breastfeeding or are planning to become pregnant during the study.
- Positive pregnancy test at screening.
- Presence of clinically significant physical, laboratory, vital signs, or ECG findings.
- Blood lead level > 3.3 μg/dL(=33.0 μg/L) at screening.
- galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption.
- Receipt of any investigational agent or study drug within 4 weeks prior to screening.
- Patients with history of alcohol or drug abuse.
- Subjects who donated whole blood within 2 months, donated blood components within 1 month.
- Subjects who have participated and taken investigational drug within 1 month prior to study drug administration.
- Subjects who the investigator considers inappropriate for the study due to other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul ST. Mary's Hospital.
Seoul
About this study
Official title: An Open-label, Randomized, Multiple Dose, Parallel Study to Assess Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea(IBS-D)
This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.
- Conditions
- Diarrhea
- Being tested
- DWJ1230, DWB2001
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1230Drug
Daewoong Pharmaceutical
DWB2001Drug
Daewoong Bio
| Study group | Role | What they receive |
|---|---|---|
| DWJ1230 | Experimental | Not described Receives: Drug: DWJ1230 |
| DWB2001 | Experimental | Not described Receives: Drug: DWB2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the concentration of lead in blood after administration of Investigational Product
Measured: Day 7
Secondary outcomes (2)
To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product
Measured: Day 7
To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start22 Aug 2022
- Primary completion6 Feb 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT05816681
- Sponsor's protocol ID
- DWJ1230101
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple Dose, Parallel Study to Assess Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea(IBS-D)
- ClinicalTrials.gov ID
- NCT05816681
- Acronym / sponsor ID
- DWJ1230101
- Conditions
- Diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- 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.
This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1230 | Experimental | Drug: DWJ1230 |
| DWB2001 | Experimental | Drug: DWB2001 |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
- Male or Female subjects aged between 19 and 60 years at screening.
- Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information.
Key exclusion criteria (16 listed)
- No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
- Identified or strongly suspected organic cause to diarrhea.
- Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
- History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
- Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
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 |
|---|---|---|
| DWJ1230Daewoong Pharmaceutical | Drug | DWJ1230 |
| DWB2001Daewoong Bio | Drug | DWB2001 |
Primary outcome
To assess the concentration of lead in blood after administration of Investigational Product
Time frame: Day 7
2 secondary outcomes
To assess blood concentration of other Class I(Cadmium, Arsenic, Mercury) after administration of Investigational Product
Time frame: Day 7
To assess blood concentration of other Class IIa(Cobalt, Nickel) and of aluminium after administration of Investigational Product
Time frame: Day 7
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 19 Apr 2023.
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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 1 study testing DWJ1230 and DWB2001 in people with Diarrhea, 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 4 inclusion and 16 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 19 Apr 2023. 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 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.
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?
To assess the concentration of lead in blood after administration of Investigational Product (time frame: Day 7). 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 19 Apr 2023.