Esophagitis, RefluxPhase 2NCT02463643
To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
A Phase 2 study testing Z-215 10mg, Z-215 20mg and Rabeprazole Sodium in people with Esophagitis, Reflux, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophagitis, Reflux
- What is being tested?
- Z-215 10mg, Z-215 20mg and Rabeprazole Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 503 participants
- Where
- 1 siteJapan
- Study dates
- May 2015to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In observation period, the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 20% (96 participants) or more of the total participants.
- Outpatient (including inpatient for examination)
Who cannot join
- Participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, Barrett's esophagus ( columnar epithelium metaplasia>=3 cm ) or high-grade dysplasia.However, participants with Schatzki's ring ( >=20mm ) are allowed to be included.
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating>=3mm) within 28 days prior to observation period . Participants with above disease at endoscopy during the observation period.
- Participants with Zollinger-Ellison syndrome.Participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others.
- Participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis
The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
- Conditions
- Esophagitis, Reflux
- Being tested
- Z-215 10mg, Z-215 20mg, Z-215 Placebo, Rabeprazole Sodium, Rabeprazole Sodium Placebo
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-215 10mgDrug
Z-215 10mg, capsules
Z-215 20mgDrug
Z-215 20mg, capsules
Z-215 PlaceboDrug
Z-215 placebo-matching capsules
Rabeprazole SodiumDrug
Rabeprazole Sodium 10mg tablets
Rabeprazole Sodium PlaceboDrug
Rabeprazole Sodium Placebo placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Z-215 10 mg/day | Experimental | Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo Receives: Drug: Z-215 10mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo |
| Z-215 20 mg/day | Experimental | Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo Receives: Drug: Z-215 20mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo |
| Z-215 40 mg/day | Experimental | Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo Receives: Drug: Z-215 20mg; Drug: Rabeprazole Sodium Placebo |
| Rabeprazole Sodium 10 mg/day | Active comparator | Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium Receives: Drug: Z-215 Placebo; Drug: Rabeprazole Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Measured: 8 weeks
Secondary outcomes (1)
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagitis, RefluxStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463643
- Sponsor's protocol ID
- Z215-01
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT02463643
- Acronym / sponsor ID
- Z215-01
- Conditions
- Esophagitis, Reflux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Jun 2015 (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 Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Z-215 10 mg/day | Experimental | Drug: Z-215 10mg, Drug: Z-215 Placebo, Drug: Rabeprazole Sodium PlaceboDrug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo |
| Z-215 20 mg/day | Experimental | Drug: Z-215 20mg, Drug: Z-215 Placebo, Drug: Rabeprazole Sodium PlaceboDrug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo |
| Z-215 40 mg/day | Experimental | Drug: Z-215 20mg, Drug: Rabeprazole Sodium PlaceboDrug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo |
| Rabeprazole Sodium 10 mg/day | Active comparator | Drug: Z-215 Placebo, Drug: Rabeprazole SodiumDrug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In observation period, the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 20% (96 participants) or more of the total participants.
- Outpatient (including inpatient for examination)
Key exclusion criteria (4 listed)
- Participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, Barrett's esophagus ( columnar epithelium metaplasia>=3 cm ) or high-grade dysplasia.However, participants with Schatzki's ring ( >=20mm ) are allowed to be included.
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating>=3mm) within 28 days prior to observation period . Participants with above disease at endoscopy during the observation period.
- Participants with Zollinger-Ellison syndrome.Participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others.
- Participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .
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-215 10mgZ-215 10mg, capsules | Drug | Z-215 10 mg/day |
| Z-215 20mgZ-215 20mg, capsules | Drug | Z-215 20 mg/day, Z-215 40 mg/day |
| Z-215 PlaceboZ-215 placebo-matching capsules | Drug | Rabeprazole Sodium 10 mg/day, Z-215 10 mg/day, Z-215 20 mg/day |
| Rabeprazole SodiumRabeprazole Sodium 10mg tablets | Drug | Rabeprazole Sodium 10 mg/day |
| Rabeprazole Sodium PlaceboRabeprazole Sodium Placebo placebo-matching tablets | Drug | Z-215 10 mg/day, Z-215 20 mg/day, Z-215 40 mg/day |
Primary outcome
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Time frame: 8 weeks
1 secondary outcome
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Time frame: 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 2 Jul 2017.
Related trials for Esophagitis, Reflux
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
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 2 study testing Z-215 10mg, Z-215 20mg and Rabeprazole Sodium in people with Esophagitis, Reflux, 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 2 Jul 2017. 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?
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis (time frame: 8 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 2 Jul 2017.