Gastroesophageal Reflux Disease MedDRA version: 9.1 Level: LLT Classification code 10018203 Term: GERD
Conditions
Interventions
Product Name: ADX10059
Pharmaceutical Form: Capsule*
CAS Number: 757950-09-7
Current Sponsor code: ADX10059
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-mg
Ph
Sponsors
Addex Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be invited to participate if he/she meets the following inclusion criteria: 1. is willing and able to provide written informed consent 2. is male or female and aged 18 to 70 years, inclusive 3. is diagnosed with typical GERD and is well controlled on a standard clinical symptom control dose of PPI treatment, defined as symptom free on >= 5 out of 7 days and presenting with == 4 out of 7 days or moderate/severe symptoms on >= 2 out of 7 days off their PPI treatment, as confirmed from the eDiary data recorded on Days -8 to -2 inclusive 5. has a body mass index (BMI) of ==65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from study participation if he/she meets any of the following criteria: 1. has exclusively atypical symptoms of GERD, such as coughing, sore throat, respiratory symptoms etc. (i.e. atypical symptoms in the absence of heartburn and / or regurgitation) 2. has symptoms that have been shown not to be associated with GERD, acid or non-acid 3. has a history of erosive oesophagitis as demonstrated by endoscopy within the previous 12 months of Grade B or worse (Los Angeles classification grading score) 4. has a documented history of hiatus hernia > 3 cm 5. has a current diagnosis of co-existing psychiatric disease that, according to the investigator, could interfere with the conduct of the study 6. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient’s safety 7. has clinically significant abnormal laboratory parameters at Screening, in particular, liver or renal functions tests greater than twice the upper limit of normal (ULN) or any other clinically significant biochemical or haematological abnormality as determined by the investigator 8. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C 9. is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, doublebarrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening and prior to randomisation on Day -1 10. is an habitual user of recreational drugs (including amphetamine, methamphetamine, cocaine and opiates), and who has used them within 14 days prior to Screening or has a positive test for drugs of abuse at Screening 11. has received sodium valproate or topiramate within 30 days of Screening 12. has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study, including but not limited to coronary artery disease, chronic obstructive pulmonary disease, arrhythmias, diabetes and epilepsy 13. has received any investigational drug within 30 days of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy on GERD symptoms (heartburn and/or regurgitation) of ADX10059 as a monotherapy compared with placebo when taken twice daily for 15 days, by patients with GERD.;Secondary Objective: • To evaluate the efficacy of ADX10059 compared with placebo on: heartburn, regurgitation, sleep disturbance due to GERD, occurrence of nocturnal and post-prandial GERD, patient and investigator global assessment of study medication, requirement for rescue medication, Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM) and Hospital Anxiety and Depression Score (HADS) • To evaluate the safety and tolerability after repeated administration of ADX10059 • In a subset of patients, to evaluate the mechanism of action and pharmacokinetics (PK) of ADX10059 in GERD;Primary end point(s): Primary efficacy endpoint: The number of GERD symptom (heartburn and/or regurgitation) free days in week 2 of study medication (Days 8 to 14) adjusted for baseline will be evaluated. Baseline is defined as the last 7 days prior to randomisation (Day -8 to -2). | — |
Countries
Austria, Belgium, France, Germany
Outcome results
None listed