Gastroesophageal RefluxPhase 2NCT00820079
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
A Phase 2 study testing ADX10059 in people with Gastroesophageal Reflux, run by Addex Pharma S.A. at 11 sites in 4 countries.
Trial summary
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux. 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
- 120 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Dec 2008to Oct 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
- well controlled on a standard clinical symptoms controlled dose of PPI treatment
- 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
- hiatus hernia > 3 cm
- current diagnosis of co-existing psychiatric disease
- known clinically significant allergy or known hypersensitivity to drugs
Show all 9Show fewer
- 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
11 sites in 4 countries.
11 sites in 4 countries
Germany6 sites
Berlin
Berlin
Dresden
Dresden
Gorlitz
Görlitz
Leipzig
Leipzig
Madgeburg 12
Magdeburg
Magdeburg 13
Magdeburg
About this study
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)
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
- Conditions
- Gastroesophageal Reflux
- Being tested
- ADX10059, ADX10059 Matching Placebo
- Keywords
- Gastroesophageal reflux, 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
ADX10059 Matching PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| ADX10059 120 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 2 of study medication treatment
Measured: 2 weeks
Secondary outcomes (5)
GERD symptoms
Measured: 2 weeks
Sleep disturbance
Measured: 2 weeks
Use of antacid rescue medication
Measured: 2 weeks
Global assessment of GERD
Measured: 2 weeks
Effect on lower oesophageal sphincter and reflux episodes
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addex Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820079
- Sponsor's protocol ID
- ADX10059-204
- Other IDs
- 2008-005104-10, 2008
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21320138
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. 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, 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)
- ClinicalTrials.gov ID
- NCT00820079
- Acronym / sponsor ID
- ADX10059-204
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal reflux, Heartburn, Regurgitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Addex Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- First posted
- 9 Jan 2009 (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.
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX10059 120 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
- well controlled on a standard clinical symptoms controlled dose of PPI treatment
- body mass index ≤32 kg/m2
Key exclusion criteria (9 listed)
- 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
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 120 mg |
| ADX10059 Matching Placebooral administration | Drug | ADX10059 Matching Placebo |
Primary outcome
Number of GERD symptom free days in week 2 of study medication treatment
Time frame: 2 weeks
5 secondary outcomes
GERD symptoms
Time frame: 2 weeks
Sleep disturbance
Time frame: 2 weeks
Use of antacid rescue medication
Time frame: 2 weeks
Global assessment of GERD
Time frame: 2 weeks
Effect on lower oesophageal sphincter and reflux episodes
Time frame: 2 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 24 Dec 2009.
- Derived from this study: PubMed 21320138Zerbib 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.
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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.
11 sites in 4 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 11 sites in 4 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 9 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 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, France, Austria, Belgium. 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 2 of study medication treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820079, which also lists 1 linked publication.
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 24 Dec 2009.