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Non-erosive Reflux DiseasePhase 3NCT03591653

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Study to Evaluate the Efficacy and Safety of LXI-15028 in Non-erosive Reflux Disease in Chinese Patients for 4 Weeks

A Phase 3 study testing LXI-15028 in people with Non-erosive Reflux Disease, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is one multi-center, randomized, double-blind, parallel-group, placebo controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg in treatment of non-erosive reflux disease in Chinese patients for 4 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-erosive Reflux Disease
What is being tested?
LXI-15028
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
1 siteChina
Study dates
29 Oct 2018to 26 Nov 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject who volunteers to sign the written informed consent form approved by the independent ethics committee and agrees to participate in this study prior to the initiation of any study procedures.
  • Subject who is able to understand and follow the protocol requirements and agrees to participate in all the study visits.
  • Male or female subjects with age ≥ 18 years.
  • Having experienced heartburn (burning or pain behind the breastbone) and regurgitation (acid taste in the mouth and discomfort movement of materials upwards from the stomach) symptoms at least three months prior to screening.
  • Having experienced heartburn and regurgitation within 7 days prior to screening, with the frequency and severity in symptom assessment meeting at least one of the following items:
  • Mild heartburn for at least 2 days, with regurgitation;
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  • Mild regurgitation for at least 2 days, with heartburn;
  • Moderate or more severe heartburn for at least 1 day, with regurgitation;
  • Moderate or more severe regurgitation for at least 1 day, with heartburn. (Note: To be determined by using the RDQ [item a, b, e, f] completed by subject.) And the RDQ symptom assessment before randomization (Visit 2) still meets the above criteria.
  • Within 14 days before study initiation, the subject has been confirmed with no mucosal damage through upper gastrointestinal endoscopy based on Los Angeles (LA) classification. And non-erosive reflux disease is clinically diagnosed by the investigator.
  • Subject who agrees to use appropriate medical method for contraception from the signature of the informed consent form to 28 days after the last dose of study medication (not including women in medically sterile state):
  • Women under medically sterile state can participate in this study, for example, postmenopausal state (spontaneous amenorrhea at least for 12 months), post hysterectomy, post bilateral salpingectomy and post bilateral oophorectomy;
  • Appropriate medical contraceptive measures include intrauterine device, physical barrier (male condom, female condom), subcutaneous implant, sustained release contraceptive injection, bilateral salpingectomy and bilateral vasoligation. Note: Use of oral contraceptives is not allowed during the course of study, and dual contraceptive methods are recommended, as to ensure no occurrence of pregnancy during the course of study.

Who cannot join

  • Subject who had participated in this study previously, or had participated in other P-CAB drug clinical studies.
  • Participation in other clinical study within 3 months prior to screening, except for the two following circumstances:
  • The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey) and is judged by investigators to have no interference with the efficacy and safety evaluation in the present study;
  • Subject had signed the informed consent form and participated in another study (NC821602) sponsored by this sponsor in the same study site, but had been withdrawn from that study prior to the start of any treatment.
  • Subjects who participate in the plan or conduction of this study (e.g., the sponsor or staff of the study site).
  • Women who are pregnant or lactating.
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  • Subject who is known to be allergic to the active ingredient or Talcid® of the investigational product (including esomeprazole).
  • Subject who is unable to undertake an upper gastrointestinal endoscopy.
  • Subject who is unable to complete the subject's diary by oneself.
  • Subject who has history of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder or other mental disorder.
  • Subject who is diagnosed as erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcer or duodenal ulcer within two months prior to screening.
  • Subject who has symptoms such as odynophagia, serious dysphagia, bleeding, decreased body weight, anemia or hematochezia that represent "warning" to presume gastrointestinal malignant disease, unless the possibility of the malignant disease is excluded through an endoscopy.
  • History of malignant tumor within 5 years prior to screening (if the subject's basal cell carcinoma or cervical carcinoma in situ has been cured, he/she will be allowed to participate in this study).
  • Subject who is diagnosed as achalasia of the cardia, secondary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), Zollinger-Ellison syndrome or eosinophilic esophagitis.
  • Subject with history of gastrointestinal surgery, except simple fenestration, appendectomy, cholecystectomy or endoscopic resection of benign tumor.
  • Subject who plans to be hospitalized for receiving selective surgery during the study.
  • Subject with non-reflux-related esophageal stenosis, hiatus hernia, gastroesophageal varices, active peptic ulcer, gastric bleeding or malignant tumor that is found in upper gastrointestinal endoscopy.
  • Subject with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, endocrine or central nervous system disease as judged by investigators.
  • Subject with history of chronic alcohol consumption (more than 14 cups per week, each cup corresponds to 360 mL beer or 150 mL wine or 45 mL liquor) or drug abuse within 5 years prior to screening.
  • Use of any PPI, P-CAB or other drugs related to the treatment of GERD (including H2-receptor antagonist, prostaglandin or mucosal protective agent), or any other antiemetic, emetic drugs within two weeks prior to the initiation of study treatment.
  • Subject who needs non-steroidal anti-inflammatory drugs (NSAIDs) during the study, unless the subject had started to use low dose aspirin (≤ 100 mg/day) prior to screening.
  • Use of potent-to-moderate cytochrome metabolism enzyme CYP3A4 inhibitor or inducer within 4 weeks prior to study treatment, including but not limited to the following drugs:
  • CYP3A4 inhibitors: Ketoconazole, Indinavir, Saquinovir, Atazanavir, Amprenavir, Fosamprenavir, Nefazodone, Itraconazole, Telithromycin, Fluconazole, Troleandomycin, Cimetidine, Aprepitant, Fluvoxamine, Amiodarone, Ritonavir, Erythromycin, Clarithromycin, and Diltiazem;
  • CYP3A4 inducers: Barbiturate, Phenytoin, Rifampin, St John's wort, Carbamazepine, Dexamethasone, Rifabutin, and Phenobarbital etc.
  • Subject currently using antipsychotic drug, antidepressant agent or anti-anxiety agent.
  • Any of the following laboratory abnormalities at screening:
  • AST≥2 x upper limit of normal (ULN);
  • ALT≥2 x ULN;
  • ALP≥2 x ULN;
  • γ-GT≥2 x ULN;
  • Total bilirubin ≥2 x ULN;
  • BUN (or urea) ≥1.5 x ULN;
  • Creatinine ≥1.5 x ULN.
  • Subject with clinically significant abnormality in ECG at screening, including serious arrhythmia, multifocal premature ventricular contraction (PVC), second degree or above atrioventricular block, prolonged QT interval (QTc ≥ 450 ms for male, QTc ≥ 470 ms for female).
  • Current infection of human immune deficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) confirmed by tests.
  • Judged by the investigator, there are other conditions rendering the subject's illegibility for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 in the Treatment of Non-erosive Reflux Disease in Chinese Patients for 4 Weeks

This is one multi-center, randomized, double-blind, parallel-group, placebo controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg in treatment of non-erosive reflux disease in Chinese patients for 4 weeks.

Screening-eligible subjects will be randomized into LXI-15028 50mg group or placebo group at Visit 2 (Day 0) according to the ratio of 1:1 and receive study treatment for 4 weeks. They will start to take the investigational products in the following morning of Visit 2 (Day 1) and start to complete the subject's diary from the day of study treatment initiation. After 2 weeks of study treatment, subjects will return to the study site and complete Visit 3, after which receive study treatment for another 2 weeks and then complete Visit 4. On the day of Visit 4, subjects will not take any drug. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of study medication.

Being tested
LXI-15028, Placebo
Medical subject headings
Non-Erosive Reflux Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LXI-15028Drug

    The investigational products are administrated orally, once in the morning every day, and each dose includes one tablet of investigational products (LXI-15028 50mg active agent or placebo). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 weeks.

  • PlaceboDrug

    Placebo

Study groups in NCT03591653
Study groupRoleWhat they receive
LXI-15028 50mg groupExperimentalNot described
Receives: Drug: LXI-15028
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of main symptoms

    Resolution rate of main symptoms (heartburn, regurgitation) at Week 4: percentage of patients with complete resolution of main symptoms (for consecutive 7 days) at Week 4. Note: At Week 4, Reflux Disease Questionnaire (RDQ) (item a, b, e, f) is used to evaluate all main symptoms during previous consecutive 7 days. Complete resolution is defined as the main symptoms are completely resolved and do not occur.

    Measured: 4 weeks after receiving oral doses

Secondary outcomes (3)

  1. Resolution of main symptoms

    Resolution rate of main symptoms (heartburn, regurgitation) at Week 2: percentage of patients with complete resolution of main symptoms (for consecutive 7 days) at Week 2. The main symptoms are evaluated using RDQ.

    Measured: 2 week after receiving oral doses

  2. Symptom improvement

    Change of Reflux Disease Questionnaire (RDQ) score (including severity score and frequency score) of each post-treatment visit from baseline;Symptom assessment based on subject diary;

    Measured: 4 weeks after receiving oral doses

  3. Life quality improvement

    Change of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score of each post-treatment visit from baseline.

    Measured: 4 weeks after receiving oral doses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start29 Oct 2018
  3. Primary completion30 Oct 2019
  4. Study completion26 Nov 2019

Resources

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
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591653
Sponsor's protocol ID
NC821603
Status last verified
Apr 2020
First submitted
9 Jul 2018
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LXI-15028 in people with Non-erosive Reflux Disease, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

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 13 inclusion and 36 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 8 Apr 2020. 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 China. 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 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?

Resolution of main symptoms (time frame: 4 weeks after receiving oral doses). 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 NCT03591653.

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 8 Apr 2020.

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