A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multi-centre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 in patients with Gastroesophageal Reflux Disease (GERD) who are partial responders to proton pump inhibitor (PPI) treatment.
- Conditions
- Gastroesophagal Reflux DiseaseMedDRA version: 9.1Level: LLTClassification code 10018203Term: GERD
- Registration Number
- EUCTR2008-005105-18-DE
- Lead Sponsor
- Addex Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
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 a partial responder to a stable standard
clinical symptom control” dose of PPI therapy. A partial responder is defined as a
patient who experiences symptom improvement on PPI treatment but who has
residual moderate or severe typical symptoms (heartburn or regurgitation) on at
least 2 days / week but no more than 5 days / week whilst on their standard PPI
dose (defined as the indicated dose for the treatment of clinical symptoms), as
confirmed from the eDiary data recorded on Days -8 to -2 inclusive
4. has a body mass index (BMI) of =32 kg/m2
5. 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 been treated or is currently treated with a dose of PPI greater than the dose
indicated for clinical symptom control of GERD
5. has a documented history of hiatus hernia > 3 cm
6. has a current diagnosis of co-existing psychiatric disease that, according to the investigator, could interfere with the conduct of the study
7. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient’s safety
8. 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
9. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C
10. is pregnant or breast-feeding. Female patients who are of child-bearing potential
must be using adequate contraceptive methods with a low failure rate 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
11. 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
12. has received sodium valproate or topiramate within 30 days of Screening
13. 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
14. 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