Gastroesophageal Reflux DiseasePhase 3NCT02860624
Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
A Phase 3 study testing 10 mg ilaprazole and 40mg esomeprazole in people with Gastroesophageal Reflux Disease, run by Livzon Pharmaceutical Group Inc..
Trial summary
This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- 10 mg ilaprazole and 40mg esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Apr 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients will be eligible for enrollment if they:
- are 18-70 years of age,
- have at least one of the two symptoms, heartburn and reflux,
- have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.
Who cannot join
- Patients will be ineligible if they:
- have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
- have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
- have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
- participated in a clinical trial with an investigational drug or device within the past three months,
- have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
- have alcoholic intemperance, drug addiction or any other improper habits.
About this study
Official title: Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- 10 mg ilaprazole, 40mg esomeprazole
- 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.
10 mg ilaprazoleDrug
Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks
40mg esomeprazoleDrug
One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 10 mg ilaprazole | Experimental | Not described Receives: Drug: 10 mg ilaprazole |
| 40 mg esomeprazole | Active comparator | Not described Receives: Drug: 40mg esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startDec 2011
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860624
- Sponsor's protocol ID
- Livzon-IY-81149R-11-01
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
Publications
Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.
PubMed 29540336
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
- ClinicalTrials.gov ID
- NCT02860624
- Acronym / sponsor ID
- Livzon-IY-81149R-11-01
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- First posted
- 9 Aug 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 study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg ilaprazole | Experimental | Drug: 10 mg ilaprazole |
| 40 mg esomeprazole | Active comparator | Drug: 40mg esomeprazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting patients will be eligible for enrollment if they:
- are 18-70 years of age,
- have at least one of the two symptoms, heartburn and reflux,
- have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.
Key exclusion criteria (8 listed)
- Patients will be ineligible if they:
- have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
- have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
- have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
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 |
|---|---|---|
| 10 mg ilaprazoleTwo 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks | Drug | 10 mg ilaprazole |
| 40mg esomeprazoleOne 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks | Drug | 40 mg esomeprazole |
Primary outcome
Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
Time frame: week 8
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 9 Aug 2016.
- Derived from this study: PubMed 29540336Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10 mg ilaprazole and 40mg esomeprazole in people with Gastroesophageal Reflux Disease, run by Livzon Pharmaceutical Group Inc..
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 8 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels. (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860624, which also lists 1 linked publication.
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 9 Aug 2016.