EUCTR2008-005104-10-DE
Active, not recruiting
Not Applicable
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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Addex Pharma SA
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 14 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 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
- •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
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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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