Lesogaberan in Chinese Patients With Refractory Reflux Symptoms

NCT ID: NCT02818309

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Lesogaberan may be used in Chinese GERD patients with partial response to PPI.

Detailed Description

To test the efficacy and safety of lesogaberan.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lesogaberan

Lesogaberan

Group Type: EXPERIMENTAL

Lesogaberan

Intervention Type: DRUG

120 mg bid

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Lesogaberan

120 mg bid

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

AZD3355; Placebo for AZD3355

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping-Huei Tseng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

201407100MIPA

Identifier Type: -

Identifier Source: org_study_id