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OpenTrials
Completed

NCT Number: NCT00820079

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

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

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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

Wien, Vienna, Austria

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
  • 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

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 2 of study medication treatment

    Time frame: 2 weeks

Secondary outcomes

  1. GERD symptoms

    Time frame: 2 weeks

  2. Sleep disturbance

    Time frame: 2 weeks

  3. Use of antacid rescue medication

    Time frame: 2 weeks

  4. Global assessment of GERD

    Time frame: 2 weeks

  5. Effect on lower oesophageal sphincter and reflux episodes

    Time frame: 2 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, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)

Important dates

Study start
2008
Primary completion
2009
First posted
Jan 9, 2009
Registry last updated
Dec 24, 2009

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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