Stomach UlcerPhase 1NCT02710994
Pharmacodynamics and Safety of CDFR0209
A Phase 1 study testing CDFR0209 and Losec in people with Stomach Ulcer and Gastroesophageal Reflux, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stomach Ulcer, Gastroesophageal Reflux
- What is being tested?
- CDFR0209 and Losec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Mar 2015
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Who cannot join
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM
- Positive result in urea breath test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
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- Subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate
- Previous whole blood donation within 60 days or component blood donation within 30 days
- Previous participation of other trial within 90 days
- Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University Medical Center
Suwon, Gyeonggi-do, 443-380
About this study
Official title: A Randomized, Open Label, Two-way Crossover Designed Clinical Trial to Investigate the Pharmacodynamics and the Safety Between Repeated Doses of CDFR0209 in Healthy Male Volunteers
This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers
Read the detailed description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before dosing (Day -2).
On Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24 hours.
On Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours after dosing.
From Day 2 ~ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing.
After 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover manner and ambulatory intragastric pH recording was performed.
- Conditions
- Stomach Ulcer, Gastroesophageal Reflux
- Being tested
- CDFR0209, Losec
- Keywords
- Immediate release omeprazole, Integrated gastric acidity
- Medical subject headings
- Stomach Ulcer, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDFR0209Drug
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg
LosecDrug
Losec 40 mg
| Study group | Role | What they receive |
|---|---|---|
| CDFR0209, Then Losec | Experimental | Subjects first received CDFR0209 each morning in a fasting state for 7 days. After a washout period of 14 days, they then received Losec 40 mg in a fasting state each morning for 7 days. Receives: Drug: CDFR0209; Drug: Losec |
| Losec, Then CDFR0209 | Experimental | Subjects first received Losec 40 mg each morning in a fasting state for 7 days. After a washout period of 14 days, they then received CDFR0209 in a fasting state each morning for 7 days. Receives: Drug: CDFR0209; Drug: Losec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent decrease from baseline in integrated gastric acidity after 7th dose
Data for 24 hour gastric pH were acquired at baseline (day -1) and day 7 of dosing with either Losec 40 mg or CDFR0209.
Percent decrease from baseline in integrated gastric acidity after 7th dose = [Baseline integrated acidity - Day 7 integrated acidity]/ Baseline integrated acidity × 100.
Measured: Day 7 upto 24 hours
Secondary outcomes (1)
Mean percent decrease from baseline in integrated gastric acidity after 1st dose
Data for 24 hour gastric pH were acquired at baseline (day -1) and day 1 of dosing with either Losec 40 mg or CDFR0209.
Percent decrease from baseline in integrated gastric acidity after 1st dose = [Baseline integrated acidity - Day 1 integrated acidity]/ Baseline integrated acidity × 100.
Measured: Day 1 upto 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach UlcerStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- CTC Bio, Inc.
- Responsible party
- Principal investigator, Doo-Yeoun Cho, Ajou University School of Medicine
- Investigators
- Doo-Yeoun Cho, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710994
- Sponsor's protocol ID
- MED-CT1-14-085
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two-way Crossover Designed Clinical Trial to Investigate the Pharmacodynamics and the Safety Between Repeated Doses of CDFR0209 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02710994
- Acronym / sponsor ID
- MED-CT1-14-085
- Conditions
- Stomach Ulcer, Gastroesophageal Reflux
- Keywords
- Immediate release omeprazole, Integrated gastric acidity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- CTC Bio, Inc.
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Mar 2016 (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.
This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers
Detailed description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before dosing (Day -2).
On Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24 hours.
On Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours after dosing.
From Day 2 ~ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing.
After 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover manner and ambulatory intragastric pH recording was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDFR0209, Then Losec | Experimental | Drug: CDFR0209, Drug: LosecSubjects first received CDFR0209 each morning in a fasting state for 7 days. After a washout period of 14 days, they then received Losec 40 mg in a fasting state each morning for 7 days. |
| Losec, Then CDFR0209 | Experimental | Drug: CDFR0209, Drug: LosecSubjects first received Losec 40 mg each morning in a fasting state for 7 days. After a washout period of 14 days, they then received CDFR0209 in a fasting state each morning for 7 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Key exclusion criteria (11 listed)
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM
- Positive result in urea breath test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
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 |
|---|---|---|
| CDFR0209Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg | Drug | CDFR0209, Then Losec, Losec, Then CDFR0209 |
| LosecLosec 40 mg | Drug | CDFR0209, Then Losec, Losec, Then CDFR0209 |
Primary outcome
Mean percent decrease from baseline in integrated gastric acidity after 7th dose
Time frame: Day 7 upto 24 hours
Data for 24 hour gastric pH were acquired at baseline (day -1) and day 7 of dosing with either Losec 40 mg or CDFR0209. Percent decrease from baseline in integrated gastric acidity after 7th dose = [Baseline integrated acidity - Day 7 integrated acidity]/ Baseline integrated acidity × 100.
1 secondary outcome
Mean percent decrease from baseline in integrated gastric acidity after 1st dose
Time frame: Day 1 upto 24 hours
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 17 Mar 2016.
- 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.
Doo-Yeoun Cho, MD principal investigator
Ajou University School of Medicine
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 CDFR0209 and Losec in people with Stomach Ulcer and Gastroesophageal Reflux, run by Ajou University School of Medicine 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 11 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 17 Mar 2016. 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?
Mean percent decrease from baseline in integrated gastric acidity after 7th dose (time frame: Day 7 upto 24 hours). 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 17 Mar 2016.