Lesogaberan in Chinese Patients With Refractory Reflux Symptoms

NCT02818309 | Unknown Phase 2 DMC

• 1 other identifier: 201407100MIPA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (8)

• Time to treatment response as assessed by the symptom questionnaire RESQ-eD

  3 years

• Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD

  3 years

• The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD

  3 years

• The change from baseline for each separate symptom domain of the RESQ-eD

  3 years

• Patients' consumption of rescue antacid medication over the 4 week treatment period

  3 years

Study Arms (2)

Lesogaberan

EXPERIMENTAL

Lesogaberan

Drug: Lesogaberan

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lesogaberan DRUG

120 mg bid

Also known as: AZD3355

Lesogaberan

Placebo DRUG

Placebo

Also known as: Placebo for AZD3355

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ping-Huei Tseng, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 29, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)