EUCTR2008-005105-18-NL
Active, not recruiting
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophagal Reflux Disease
- Sponsor
- Addex Pharma SA
- Enrollment
- 320
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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
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 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
Outcomes
Primary Outcomes
Not specified
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