ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)

Addex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: ADX10059 Matching Placebo; Drug: ADX10059

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810485

ADX10059-205

2008-005105-18

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

Enrollment: 298 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of typical GERD
• partial responder to a stable standard clinical symptoms control dose of PPI therapy
• body mass index ≤ 32 kg/m2

Exclusion criteria

• exclusively atypical symptoms of GERD
• symptoms that have been shown not to be associated with GERD
• erosive oesophagitis
• treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD
• hiatus hernia > 3 cm
• current diagnosis of co-existing psychiatric disease
• known clinical significant allergy or known hypersensitivity to drugs
• is pregnant or breast-feeding
• has received sodium valproate or topiramate within 30 days of Screening
• has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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298 participants in 4 patient groups, including a placebo group

ADX10059 50 mg

Experimental group

Description:

twice-daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 100 mg

Experimental group

Description:

twice-daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 150 mg

Experimental group

Description:

twice-daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 Matching Placebo

Placebo Comparator group

Description:

twice-daily

Treatment:

Drug: ADX10059 Matching Placebo