Gastroesophageal RefluxPhase 2NCT00810485
ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)
A Phase 2 study testing ADX10059 in people with Gastroesophageal Reflux, run by Addex Pharma S.A. at 40 sites in 5 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- ADX10059
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 40 sitesin 5 countries
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
United States28 sites
Study site
Anaheim, California
Study site
Baytown, Texas
Study site
Charleston, South Carolina
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Fargo, North Dakota
Study site
Germantown, Tennessee
Study site
Harrisburg, North Carolina
Study site
High Point, North Carolina
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
54
Kansas City, Kansas
62
Kansas City, Kansas
Study site
Little Rock, Arizona
Study site
Moline, Illinois
71
Nashville, Tennessee
73
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
Port Orange, Florida
Study site
Raleigh, North Carolina
Study site
San Diego, California
Study site
Setauket, New York
Study site
Tucson, Arizona
Study site
Waukesha, Wisconsin
Study site
Winston-Salem, North Carolina
France6 sites
Study site
Bordeaux
Study site
Colombes
Study site
Lyon
Study site
Nantes
Study site
Nice
Study site
Rouen
Germany4 sites
Study site
Dresden
Study site
Garmisch-Partenkirchen
Study site
Magdeburg
Study site
Munich
About this study
Official 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
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
- Conditions
- Gastroesophageal Reflux
- Being tested
- ADX10059, ADX10059 Matching Placebo
- Keywords
- Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX10059Drug
oral administration
ADX10059Drug
oral administration
ADX10059Drug
oral administration
ADX10059 Matching PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| ADX10059 50 mg | Experimental | twice-daily Receives: Drug: ADX10059 |
| ADX10059 100 mg | Experimental | twice-daily Receives: Drug: ADX10059 |
| ADX10059 150 mg | Experimental | twice-daily Receives: Drug: ADX10059 |
| ADX10059 Matching Placebo | Placebo comparator | twice-daily Receives: Drug: ADX10059 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of GERD symptom free days in week 4 of study medication treatment
Measured: 4 weeks
Secondary outcomes (5)
GERD symptoms
Measured: 4 weeks
Sleep disturbance
Measured: 4 weeks
Use of antacid medications
Measured: 4 weeks
Global assessment of GERD
Measured: 4 weeks
Safety and tolerability assessments
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addex Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810485
- Sponsor's protocol ID
- ADX10059-205
- Other IDs
- 2008-005105-18, 2008
- Status last verified
- Jul 2012
- First submitted
- 17 Dec 2008
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00810485
- Acronym / sponsor ID
- ADX10059-205
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal reflux, Proton pump inhibitor, Heartburn, Regurgitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Addex Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADX10059 50 mg | Experimental | Drug: ADX10059twice-daily |
| ADX10059 100 mg | Experimental | Drug: ADX10059twice-daily |
| ADX10059 150 mg | Experimental | Drug: ADX10059twice-daily |
| ADX10059 Matching Placebo | Placebo comparator | Drug: ADX10059 Matching Placebotwice-daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX10059oral administration | Drug | ADX10059 50 mg |
| ADX10059oral administration | Drug | ADX10059 100 mg |
| ADX10059oral administration | Drug | ADX10059 150 mg |
| ADX10059 Matching Placebooral administration | Drug | ADX10059 Matching Placebo |
Primary outcome
Number of GERD symptom free days in week 4 of study medication treatment
Time frame: 4 weeks
5 secondary outcomes
GERD symptoms
Time frame: 4 weeks
Sleep disturbance
Time frame: 4 weeks
Use of antacid medications
Time frame: 4 weeks
Global assessment of GERD
Time frame: 4 weeks
Safety and tolerability assessments
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX10059 in people with Gastroesophageal Reflux, run by Addex Pharma S.A. at 40 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, France, Germany, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of GERD symptom free days in week 4 of study medication treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.