ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

Addex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: ADX10059; Drug: ADX10059 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820079

2008-005104-10

ADX10059-204

Details and patient eligibility

About

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of typical GERD
• well controlled on a standard clinical symptoms controlled dose of PPI treatment
• 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
• hiatus hernia > 3 cm
• current diagnosis of co-existing psychiatric disease
• known clinically significant allergy or known hypersensitivity to drugs
• 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

---

120 participants in 2 patient groups, including a placebo group

ADX10059 120 mg

Experimental group

Description:

Twice-daily

Treatment:

Drug: ADX10059

ADX10059 Matching Placebo

Placebo Comparator group

Description:

twice-daily

Treatment:

Drug: ADX10059 Matching Placebo