Gastroesophageal Reflux DiseasePhase 2NCT02818309
Lesogaberan in Chinese Patients With Refractory Reflux Symptoms
A Phase 2 study testing Lesogaberan in people with Gastroesophageal Reflux Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lesogaberan may be used in Chinese GERD patients with partial response to PPI. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Lesogaberan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Male or female. Females of childbearing potential must have been using a highly effective contraceptive method for at least the previous 3 months.
- Age 20-70 years, inclusive.
- Body Mass Index (BMI) 18.5 - 35.0 kg/m2, inclusive.
- Have at least 6 months history of Gastroesophageal reflux disease (GERD) symptoms (need not to have been consecutive) and endoscopy documented erosive esophagitis within 4 months.
- Continuously treated during the last 8 weeks before enrolment with daily optimised unchanged standard dose proton pump inhibitor (PPI) therapy, such as esomeprazole 40 mg, lansoprazole 30 mg, dexlansoprazole 60 mg, rabeprazole 30 mg and pantoprazole 40 mg.
Show all 9Show fewer
- Able to read and write in the local language and use the e-diary device.
- To be eligible for the screening phase the patients must have reported in the Reflux Symptom Questionnaire 7 day recall (RESQ-7) using 7 days recall of symptoms, a minimum of 3 days with a rating of at least moderate intensity on at least 1 of the following items; a burning feeling behind the breastbone or unpleasant movement of material upwards from the stomach.
- To be eligible for randomisation the patients must have recorded in the Reflux Symptom Questionnaire electronic diary (RESQ-eD) on the last 7 days before randomisation, a minimum of 3 days with a symptom intensity of at least moderate on 1 of 2 items (a burning feeling behind the breastbone or an unpleasant movement of material upwards from the stomach), or any combination of both items (eg, 1 day on 1 item and 2 days on the other).
Who cannot join
- Patients that had not experienced any GERD symptom improvement at all during PPI treatment.
- Unstable or clinically significant cardiovascular (ischemic heart disease, congestive heart failure, arrhythmia), respiratory (chronic obstructive pulmonary disease), hepatic (AST or ALT or total bilirubin > upper limit of normal), renal (>1.5 mg/dL), metabolic (serum potassium or magnesium < lower reference range), psychiatric (major depression, schizophrenia) , or gastrointestinal and esophageal disorders besides GERD (peptic ulcer, eosinophilic esophagitis).
- Current neurological disorders including nerve compression syndromes. Patients with well controlled migraine and other headache disorders could be included.
- History of clinically significant orthostatic reaction or syncope.
- History of a heart disease (including ischemic heart disease, congestive heart failure, cardiac arrhythmias, congenital long QT syndrome), or current signs or symptoms of any heart disease, or patients with clinically significant ECG abnormalities or QTcF >450 ms as determined by the investigator.
- History of, or current malignant disease (radically treated basal cell cancer was allowed).
Show all 11Show fewer
- History of clinically significant electrolyte imbalances.
- History of severe allergic or hypersensitivity reactions (such as Stevens Johnson syndrome, anaphylactic shock, angioedema-urticaria).
- Using concomitant drugs that could potentially interfere with the pharmacodynamic effects of lesogaberan (such as baclofen or supplements containing GABA), alter gastrointestinal symptoms (such as type-2 histamine receptor agonists) or cause damage to the mucosal lining of the gastrointestinal tract (such as nonsteroidal anti-inflammatory drugs or acetylsalicylic acid >162 mg/day).
- Prior surgery of the upper GI tract
- Pregnant or breastfeeding females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Lesogaberan (AZD3355) in Chinese Patients With Reflux Symptoms Refractory to Proton Pump Inhibitor Therapy: a Randomized Placebo-controlled Trial
Lesogaberan may be used in Chinese GERD patients with partial response to PPI.
Read the detailed description
To test the efficacy and safety of lesogaberan.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Lesogaberan, Placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LesogaberanDrug
Also called AZD3355
120 mg bid
PlaceboDrug
Also called Placebo for AZD3355
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lesogaberan | Experimental | Lesogaberan Receives: Drug: Lesogaberan |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response as assessed by the symptom questionnaire RESQ-eD
Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD
Measured: 3 years
Secondary outcomes (8)
Time to treatment response as assessed by the symptom questionnaire RESQ-eD
time from the day of the first dose to the first of seven consecutive days meeting the responder definition
Measured: 3 years
Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD
time from the day of the first dose to the first of seven consecutive symptom-free days
Measured: 3 years
The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD
Measured: 3 years
The change from baseline for each separate symptom domain of the RESQ-eD
Measured: 3 years
Patients' consumption of rescue antacid medication over the 4 week treatment period
Measured: 3 years
Patient compliance with treatment determined by counts of returned unused capsules at each visit during the period of randomised treatment
Measured: 3 years
Subgroup analysis of in patients with different reflux profiles categorized by impedance-pH as assessed by the symptom questionnaire RESQ-eD
Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD
Measured: 3 years
Number of participants with treatment-related adverse events as assessed by CRF_20150728
Adverse events are any untoward medical occurrences in a patient or clinical trial subject to whom a medicinal product has been administered including occurrences which are not necessarily caused by or related to that product. According to previous studies, the common adverse events of lesogaberan include paraesthesia, diarrhea, pruritus, dizziness and nausea. The serious adverse events are defined as following: 1. results in death; 2.
life-threatening; 3. requires hospitalisation or prolongation of existing hospitalisation; 4. results in persistent or significant disability or incapacity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ping-Huei Tseng, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818309
- Sponsor's protocol ID
- 201407100MIPA
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The data will not open for public use.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lesogaberan (AZD3355) in Chinese Patients With Reflux Symptoms Refractory to Proton Pump Inhibitor Therapy: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02818309
- Acronym / sponsor ID
- 201407100MIPA
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jun 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.
Lesogaberan may be used in Chinese GERD patients with partial response to PPI.
Detailed description
To test the efficacy and safety of lesogaberan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lesogaberan | Experimental | Drug: LesogaberanLesogaberan |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of informed consent prior to any study specific procedures.
- Male or female. Females of childbearing potential must have been using a highly effective contraceptive method for at least the previous 3 months.
- Age 20-70 years, inclusive.
- Body Mass Index (BMI) 18.5 - 35.0 kg/m2, inclusive.
- Have at least 6 months history of Gastroesophageal reflux disease (GERD) symptoms (need not to have been consecutive) and endoscopy documented erosive esophagitis within 4 months.
Key exclusion criteria (11 listed)
- Patients that had not experienced any GERD symptom improvement at all during PPI treatment.
- Unstable or clinically significant cardiovascular (ischemic heart disease, congestive heart failure, arrhythmia), respiratory (chronic obstructive pulmonary disease), hepatic (AST or ALT or total bilirubin > upper limit of normal), renal (>1.5 mg/dL), metabolic (serum potassium or magnesium < lower reference range), psychiatric (major depression, schizophrenia) , or gastrointestinal and esophageal disorders besides GERD (peptic ulcer, eosinophilic esophagitis).
- Current neurological disorders including nerve compression syndromes. Patients with well controlled migraine and other headache disorders could be included.
- History of clinically significant orthostatic reaction or syncope.
- History of a heart disease (including ischemic heart disease, congestive heart failure, cardiac arrhythmias, congenital long QT syndrome), or current signs or symptoms of any heart disease, or patients with clinically significant ECG abnormalities or QTcF >450 ms as determined by the investigator.
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 |
|---|---|---|
| LesogaberanAlso: AZD3355120 mg bid | Drug | Lesogaberan |
| PlaceboAlso: Placebo for AZD3355Placebo | Drug | Placebo |
Primary outcome
Treatment response as assessed by the symptom questionnaire RESQ-eD
Time frame: 3 years
Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD
8 secondary outcomes
Time to treatment response as assessed by the symptom questionnaire RESQ-eD
Time frame: 3 years
Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD
Time frame: 3 years
The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD
Time frame: 3 years
The change from baseline for each separate symptom domain of the RESQ-eD
Time frame: 3 years
Patients' consumption of rescue antacid medication over the 4 week treatment period
Time frame: 3 years
Patient compliance with treatment determined by counts of returned unused capsules at each visit during the period of randomised treatment
Time frame: 3 years
Subgroup analysis of in patients with different reflux profiles categorized by impedance-pH as assessed by the symptom questionnaire RESQ-eD
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CRF_20150728
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: No. The data will not open for public use.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Ping-Huei Tseng, MD, PhD principal investigator
National Taiwan University Hospital
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 Lesogaberan in people with Gastroesophageal Reflux Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 9 inclusion and 11 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 29 Jun 2016. 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 Taiwan. 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 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?
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?
Treatment response as assessed by the symptom questionnaire RESQ-eD (time frame: 3 years). 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 29 Jun 2016.