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ADX10059

Phase 2

Gastroesophageal Reflux | Small molecule | Gastrointestinal |Addex Therapeutics Ltd|Last Updated: Jul 16, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment418

FDA Designations

No designations recorded

Clinical trial landscape

ADX10059 · 2 trials · 1 indication

Phase 2 2
NCT00810485ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)Gastroesophageal Reflux
COMPLETED298 Analytics
NCT00820079ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)Gastroesophageal Reflux
COMPLETED120 Analytics
PHASE2COMPLETED
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
Gastroesophageal RefluxUnlock trial analytics
PHASE2COMPLETED
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
Gastroesophageal RefluxUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of GERD symptom free days in week 4 of study medication treatment
4 weeks
Number of GERD symptom free days in week 2 of study medication treatment
2 weeks

Secondary Endpoints

GERD symptoms
4 weeks
Sleep disturbance
4 weeks
Use of antacid medications
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ADX10059 50 mgEXPERIMENTALtwice-daily
ADX10059 100 mgEXPERIMENTALtwice-daily
ADX10059 150 mgEXPERIMENTALtwice-daily
ADX10059 Matching PlaceboPLACEBO_COMPARATORtwice-daily
ADX10059 120 mgEXPERIMENTALTwice-daily

Interventions

NameTypeDescription
ADX10059DRUGoral administration
ADX10059 Matching PlaceboDRUGoral administration
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites40

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 ...

Countries:United StatesFranceGermanyNetherlandsSwitzerlandAustriaBelgium
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Frequently asked questions about ADX10059

What is ADX10059 used for?

ADX10059 is an investigational small molecule being studied for the treatment of gastroesophageal reflux disease (GERD). It has been evaluated in Phase 2 clinical trials as both an add-on therapy to proton pump inhibitors and as a monotherapy in patients with GERD.

Who is developing ADX10059?

ADX10059 is being developed by Addex Therapeutics Ltd, a biopharmaceutical company listed on the stock exchange under the ticker ADXN. The company has conducted Phase 2 clinical trials for this drug candidate in patients with gastroesophageal reflux disease.

What phase is ADX10059 in?

ADX10059 is in Phase 2 clinical development. It has completed two Phase 2 trials for gastroesophageal reflux disease, with a total of 418 patients enrolled across studies in the United States and several European countries.

What clinical trials is ADX10059 in?

ADX10059 has completed two Phase 2 trials: NCT00810485, a study of ADX10059 as add-on therapy to proton pump inhibitors in 298 patients with GERD, and NCT00820079, a monotherapy study in 120 patients with GERD. Both trials were randomized, double-blind, and placebo-controlled.

Is ADX10059 FDA approved?

ADX10059 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for gastroesophageal reflux disease. The drug remains in clinical development and has not been approved for any use.