- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818309
Lesogaberan in Chinese Patients With Refractory Reflux Symptoms
Efficacy and Safety of Lesogaberan (AZD3355) in Chinese Patients With Reflux Symptoms Refractory to Proton Pump Inhibitor Therapy: a Randomized Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- 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.
- 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).
Exclusion criteria
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
Other Names:
|
Experimental: Lesogaberan
|
120 mg bid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to treatment response as assessed by the symptom questionnaire RESQ-eD
Time Frame: 3 years
|
time from the day of the first dose to the first of seven consecutive days meeting the responder definition
|
3 years
|
Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD
Time Frame: 3 years
|
time from the day of the first dose to the first of seven consecutive symptom-free days
|
3 years
|
The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD
Time Frame: 3 years
|
3 years
|
|
The change from baseline for each separate symptom domain of the RESQ-eD
Time Frame: 3 years
|
3 years
|
|
Patients' consumption of rescue antacid medication over the 4 week treatment period
Time Frame: 3 years
|
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
|
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
|
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
|
3 years
|
Number of participants with treatment-related adverse events as assessed by CRF_20150728
Time Frame: 3 years
|
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 |
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ping-Huei Tseng, MD, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastroesophageal Reflux
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- GABA Agents
- GABA-A Receptor Agonists
- GABA Agonists
- Lesogaberan
Other Study ID Numbers
- 201407100MIPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux Disease
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
King Chulalongkorn Memorial HospitalCompleted
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
PfizerTerminatedGastroesophageal Reflux DiseaseBrazil, Germany, Korea, Republic of, Belgium, Spain, Slovakia, France
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States