Overview

Lesogaberan in Chinese Patients With Refractory Reflux Symptoms

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
Lesogaberan may be used in Chinese GERD patients with partial response to PPI.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborator:
Ministry of Science and Technology, Taiwan
Treatments:
Lesogaberan
Criteria
Inclusion criteria

1. Provision of informed consent prior to any study specific procedures.

2. Male or female. Females of childbearing potential must have been using a highly
effective contraceptive method for at least the previous 3 months.

3. Age 20-70 years, inclusive.

4. Body Mass Index (BMI) 18.5 - 35.0 kg/m2, inclusive.

5. 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.

6. 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.

7. Able to read and write in the local language and use the e-diary device.

8. 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.

9. 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

1. Patients that had not experienced any GERD symptom improvement at all during PPI
treatment.

2. 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).

3. Current neurological disorders including nerve compression syndromes. Patients with
well controlled migraine and other headache disorders could be included.

4. History of clinically significant orthostatic reaction or syncope.

5. 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.

6. History of, or current malignant disease (radically treated basal cell cancer was
allowed).

7. History of clinically significant electrolyte imbalances.

8. History of severe allergic or hypersensitivity reactions (such as Stevens Johnson
syndrome, anaphylactic shock, angioedema-urticaria).

9. 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).

10. Prior surgery of the upper GI tract

11. Pregnant or breastfeeding females