A phase 2B, randomised, double-blind, placebo-controlled, parallel group,multi-centre study to investigate the efficacy, mechanism of action,pharmacokinetics, safety and tolerability of the mGluR5 negativeallosteric modulator ADX10059 as monotherapy in patients withGastroesophageal Reflux Disease (GERD)
- Conditions
- Gastroesophageal Reflux DiseaseMedDRA version: 9.1Level: LLTClassification code 10018203Term: GERD
- Registration Number
- EUCTR2008-005104-10-BE
- Lead Sponsor
- Addex Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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 = 2 days of mild heartburn and/or regurgitation per
week whilst on treatment, and is prepared to stop their standard dose of PPI
treatment from Screening to the end of the 15 day treatment period (approximately 4 weeks)
4. has mild symptoms of heartburn and/or regurgitation on = 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 =32 kg/m2
6. has an ability to communicate well with the study staff and to comply with the requirements of the entire study including compliance with eDiary completion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 with a low failure of less than 1% per year(e.g. oral contraceptive, some intra-uterine devices, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method