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)

Addex Pharma SA0 sites100 target enrollmentOctober 9, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Addex Pharma SA
Enrollment: 100
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 9, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Addex Pharma SA

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 (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

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 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