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OpenTrials
Completed

NCT Number: NCT00810485

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

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

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX10059

Drug

oral administration

ADX10059 Matching Placebo

Drug

oral administration

Primary outcomes

  1. Number of GERD symptom free days in week 4 of study medication treatment

    Time frame: 4 weeks

Secondary outcomes

  1. GERD symptoms

    Time frame: 4 weeks

  2. Sleep disturbance

    Time frame: 4 weeks

  3. Use of antacid medications

    Time frame: 4 weeks

  4. Global assessment of GERD

    Time frame: 4 weeks

  5. Safety and tolerability assessments

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Addex Pharma S.A.

Industry

Registry information

Official study title

A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

Important dates

Study start
2008
Primary completion
2009
First posted
Dec 18, 2008
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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