GERDPhase 1NCT01707901
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
A Phase 1 study testing ONO-8539 in people with GERD, run by Ono Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial summary
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- ONO-8539
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2012to Oct 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.
Who cannot join
- Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease
Read the detailed description
This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
- Conditions
- GERD
- Being tested
- ONO-8539, Placebo
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-8539Drug
Also called Experimental
Treatment
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ONO-8539 | Experimental | ONO-8539 Receives: Drug: ONO-8539 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
Daily, through a pain assessment score chart
Measured: 28 Days
Secondary outcomes (10)
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
Daily, by observation
Measured: 28 Days
To assess the tolerability of ONO-8539
Daily, through observation
Measured: 28 Days
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
Daily, through observation and a pain score chart
Measured: 28 Days
To evaluate the effect of ONO-8539 on quality of life
Daily, through Quality of life assessment questionnaires
Measured: 28 Days
To investigate the pharmacokinetics of ONO-8539
AUC, Cmax, Tmax
Concentrations of ONO-8539
Measured: 28 Days
To investigate the association among the changes in pharmacodynamics of ONO-8539
Daily observation and through Quality of life assessment questionnaires
Measured: 28 Days
To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539
Correlation between pharmacokinetic results and study specific procedure results
Measured: 28 Days
To evaluate the use of antacid in each treatment group
Daily record of frequency of use
Measured: 28 Days
To assess the safety of ONO-8539
Measured: 28 days
To investigate the association among the changes in psychological parameters of ONO-8539
Psychological parameters
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Ono 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Clinical Department, Ono Pharmaceutical Co. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707901
- Sponsor's protocol ID
- ONO-8539POE011
- Status last verified
- Oct 2015
- First submitted
- 10 Oct 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
- ClinicalTrials.gov ID
- NCT01707901
- Acronym / sponsor ID
- ONO-8539POE011
- Conditions
- GERD
- Keywords
- GERD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- First posted
- 16 Oct 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.
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease
Detailed description
This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-8539 | Experimental | Drug: ONO-8539ONO-8539 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.
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 |
|---|---|---|
| ONO-8539Also: ExperimentalTreatment | Drug | ONO-8539 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
Time frame: 28 Days
Daily, through a pain assessment score chart
10 secondary outcomes
To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
Time frame: 28 Days
To assess the tolerability of ONO-8539
Time frame: 28 Days
To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
Time frame: 28 Days
To evaluate the effect of ONO-8539 on quality of life
Time frame: 28 Days
To investigate the pharmacokinetics of ONO-8539
Time frame: 28 Days
To investigate the association among the changes in pharmacodynamics of ONO-8539
Time frame: 28 Days
To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539
Time frame: 28 Days
To evaluate the use of antacid in each treatment group
Time frame: 28 Days
To assess the safety of ONO-8539
Time frame: 28 days
To investigate the association among the changes in psychological parameters of ONO-8539
Time frame: 28 days
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 14 Oct 2015.
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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.
Study Director study director
Clinical Department, Ono Pharmaceutical Co. Ltd
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-8539 in people with GERD, run by Ono Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
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 1 inclusion and 1 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, United Kingdom. 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. Some participants in this study may receive a placebo. 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 evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion (time frame: 28 Days). 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 14 Oct 2015.