## Protocol Section
### Identification Module
**NCT ID:** NCT00820079

**Brief Title:** ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

**Official 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)

#### Organization Study ID Info
**ID:** ADX10059-204
#### Organization
**Class:** INDUSTRY
**Full Name:** Addex Pharma S.A.
#### Secondary ID Infos
**ID:** 2008-005104-10
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-12-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-12-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Start Date
**Date:** 2008-12

**Status Verified Date:** 2009-12

#### Study First Post Date
**Date:** 2009-01-09
**Type:** ESTIMATED
**Study First Submit Date:** 2009-01-08
**Study First Submit QC Date:** 2009-01-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Addex Pharma S.A.

#### Responsible Party

**Old Name Title:** Study Director

**Old Organization:** Addex Pharma SA

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

### Conditions Module

**Conditions:**

- Gastroesophageal Reflux

**Keywords:**

- Gastroesophageal reflux

- Heartburn

- Regurgitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Twice-daily

**Intervention Names:**

- Drug: ADX10059

**Label:** ADX10059 120 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** twice-daily

**Intervention Names:**

- Drug: ADX10059 Matching Placebo

**Label:** ADX10059 Matching Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ADX10059 120 mg

**Description:** oral administration

**Name:** ADX10059

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ADX10059 Matching Placebo

**Description:** oral administration

**Name:** ADX10059 Matching Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of GERD symptom free days in week 2 of study medication treatment

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Measure:** GERD symptoms

**Time Frame:** 2 weeks

**Measure:** Sleep disturbance

**Time Frame:** 2 weeks

**Measure:** Use of antacid rescue medication

**Time Frame:** 2 weeks

**Measure:** Global assessment of GERD

**Time Frame:** 2 weeks

**Measure:** Effect on lower oesophageal sphincter and reflux episodes

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wien

**Country:** Austria

**Facility:** Wien

**Location 2:**

**City:** Leuven

**Country:** Belgium

**Facility:** Leuven

**Location 3:**

**City:** Bordeaux

**Country:** France

**Facility:** Bordeaux

**Location 4:**

**City:** Lyon

**Country:** France

**Facility:** Lyon

**Location 5:**

**City:** Nantes

**Country:** France

**Facility:** Nantes

**Location 6:**

**City:** Berlin

**Country:** Germany

**Facility:** Berlin

**Location 7:**

**City:** Dresden

**Country:** Germany

**Facility:** Dresden

**Location 8:**

**City:** Gorlitz

**Country:** Germany

**Facility:** Gorlitz

**Location 9:**

**City:** Leipzig

**Country:** Germany

**Facility:** Leipzig

**Location 10:**

**City:** Magdeburg

**Country:** Germany

**Facility:** Madgeburg 12

**Location 11:**

**City:** Magdeburg

**Country:** Germany

**Facility:** Magdeburg 13

### References Module

#### References

**Citation:** Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.

**PMID:** 21320138

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004941

- Term: Esophagitis

- ID: D000005759

- Term: Gastroenteritis

- ID: D000010437

- Term: Peptic Ulcer

- ID: D000004378

- Term: Duodenal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M9444

- Name: Heartburn

- Relevance: LOW

- As Found: Unknown

- ID: M8091

- Name: Esophagitis

- Relevance: LOW

- As Found: Unknown

- ID: M8092

- Name: Esophagitis, Peptic

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M13348

- Name: Peptic Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M7552

- Name: Duodenal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

- ID: D000004942

- Term: Esophagitis, Peptic

### Misc Info Module

#### Removed Countries

- Country: Netherlands

- Country: Switzerland

- Version Holder: 2024-05-24
