Gastroesophageal Reflux DiseasePhase 2NCT01107938
Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
A Phase 2 study testing 10 mg ilaprazole, 15 mg ilaprazole and 40 mg 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, 15 mg ilaprazole and 40 mg esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 2010
- 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 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,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, 15 mg ilaprazole, 40 mg 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) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
15 mg ilaprazoleDrug
Three 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
40 mg esomeprazoleDrug
One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package 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 |
| 15 mg ilaprazole | Experimental | Not described Receives: Drug: 15 mg ilaprazole |
| 40 mg esomeprazole | Active comparator | Not described Receives: Drug: 40 mg esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with healed esophagitis at week 8
Measured: week 8
Secondary outcomes (2)
the proportion of patients healed at week 4
Measured: week 4
resolution of clinical symptoms
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 posted21 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sanren Lin, MD, Principal investigator, Peking University Third HospitalLiya Zhou, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107938
- Sponsor's protocol ID
- Livzon-IY-81149R-09
- Other IDs
- SFDA2004L00137
- Status last verified
- Apr 2010
- First submitted
- 19 Apr 2010
- Last updated
- 21 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig. 2016 Dec;36(12):985-992. doi: 10.1007/s40261-016-0446-3.
PubMed 27605258
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. 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,Phase2,Multicenter Trial in China
- ClinicalTrials.gov ID
- NCT01107938
- Acronym / sponsor ID
- Livzon-IY-81149R-09
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (estimated)
- First posted
- 21 Apr 2010 (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
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 mg ilaprazole | Experimental | Drug: 10 mg ilaprazole |
| 15 mg ilaprazole | Experimental | Drug: 15 mg ilaprazole |
| 40 mg esomeprazole | Active comparator | Drug: 40 mg 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:
Key exclusion criteria (8 listed)
- Patients will be ineligible if they:
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) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks | Drug | 10 mg ilaprazole |
| 15 mg ilaprazoleThree 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks | Drug | 15 mg ilaprazole |
| 40 mg esomeprazoleOne 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package being taken orally each morning on an empty stomach for 8 weeks | Drug | 40 mg esomeprazole |
Primary outcome
the proportion of patients with healed esophagitis at week 8
Time frame: week 8
2 secondary outcomes
the proportion of patients healed at week 4
Time frame: week 4
resolution of clinical symptoms
Time frame: week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2010.
- Derived from this study: PubMed 27605258Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig. 2016 Dec;36(12):985-992. doi: 10.1007/s40261-016-0446-3.
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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.
Sanren Lin, MD principal investigator
Peking University Third Hospital
Liya Zhou, MD principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg ilaprazole, 15 mg ilaprazole and 40 mg 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: status not confirmed, as of the sponsor's last update on 21 Apr 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haitang Hu, MD (+86 13892890474, wl1020_2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients with healed esophagitis at week 8 (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 NCT01107938, 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 21 Apr 2010.