Gastroesophageal Reflux Disease (GERD)Phase 2NCT00394472

Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

A Phase 2 study testing AZD3355 in people with Gastroesophageal Reflux Disease (GERD), run by AstraZeneca at 38 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment. Read more about this study

Who is it for?: Ages 17 to 70 years
Conditions the study is for: Gastroesophageal Reflux Disease (GERD)
What is being tested?: AZD3355
How many people: 244 participants
Where: 38 sitesin 8 countries
Study dates: Nov 2006to Jun 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Provision of written informed consent
At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
Continuous treatment with Proton Pump Inhibitor (PPI)
Ability to read and write

Who cannot join

Prior surgery of the upper gastrointestinal (GI) tract
History of clinically significant diseases other than GERD
Need for concomitant medication with drugs that may influence gastrointestinal symptoms

Trial locations and contacts

38 sites in 8 countries.

Country

City, postcode or hospital

38 sites in 8 countries

Germany8 sites

Research Site
Cologne
Research Site
Koblenz
Research Site
Ludwigshafen
Research Site
München
Research Site
Oelde
Research Site
Potsdam
Research Site
Wangen
Research Site
Wiesbaden

Other trials in Germany

Hungary8 sites

Research Site
Budapest
Research Site
Győr
Research Site
Nagykanizsa
Research Site
Pécs
Research Site
Siófok
Research Site
Szeged
Research Site
Szombathely
Research Site
Vác

Other trials in Hungary

Norway8 sites

Research Site
Ålesund
Research Site
Bergen
Research Site
Levanger
Research Site
Oslo
Research Site
Rud
Research Site
Stavanger
Research Site
Tromsø
Research Site
Trondheim

Other trials in Norway

France5 sites

Research Site
Alès
Research Site
Angers
Research Site
Bordeaux
Research Site
Lyon
Research Site
Nantes

Other trials in France

Romania4 sites

Research Site
Brasov
Research Site
Bucharest
Research Site
Satu Mare
Research Site
Târgu Mureş

Other trials in Romania

Belgium3 sites

Research Site
Brussels
Research Site
Eupen
Research Site
Wilrijk

Other trials in Belgium

Australia1 site

Research Site
Adelaide

Other trials in Australia

Netherlands1 site

Research Site
Amsterdam

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

Conditions: Gastroesophageal Reflux Disease (GERD)
Being tested: AZD3355
Keywords: Heartburn, Patient reported symptoms, Proton pump inhibitor
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.

AZD3355Drug
Also called Lesogaberan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary
Measured: Twice daily during the last seven days on treatment

Secondary outcomes (1)

Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule
Measured: An interval of one to two hours after the first intake of AZD3355 65 mg capsule

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jun 2007

First posted1 Nov 2006 (estimated)
Study startNov 2006
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00394472
Sponsor's protocol ID: D9120C00011
Other IDs: EUDRACT No 2006-003541-16
Status last verified: Feb 2013
First submitted: 31 Oct 2006
Last updated: 18 Mar 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Bjorck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.
PubMed 21402616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All Gastroesophageal Reflux Disease (GERD) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.
ClinicalTrials.gov ID: NCT00394472
Acronym / sponsor ID: D9120C00011
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Heartburn, Patient reported symptoms, Proton pump inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 1 Nov 2006 (estimated)
Results: Posted 18 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 17 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Provision of written informed consent
At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
Continuous treatment with Proton Pump Inhibitor (PPI)
Ability to read and write

Key exclusion criteria (3 listed)

Prior surgery of the upper gastrointestinal (GI) tract
History of clinically significant diseases other than GERD
Need for concomitant medication with drugs that may influence gastrointestinal symptoms

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
AZD3355Also: Lesogaberan	Drug	–

Primary outcome

Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment
Time frame: Twice daily during the last seven days on treatment
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary

1 secondary outcome

Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule
Time frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule

Results and safety

Results posted to the registry on 18 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD3355	122	113
Placebo	122	111

Primary outcome: Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment

Time frame: Twice daily during the last seven days on treatment. Number. Unit: Participants

Measure	AZD3355 n = 114	Placebo n = 118
Value	17	8

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD3355	2 of ?	28 of ?	Not reported
Placebo	0 of ?	19 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21402616Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Bjorck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

Related trials for Gastroesophageal Reflux Disease (GERD)

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

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.

Göran Hasselgren, MD study director

AstraZeneca

Guy Boeckxstaens, MD principal investigator

Academisch Medisch Centrum Universiteit van Amsterdam

38 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD3355 in people with Gastroesophageal Reflux Disease (GERD), run by AstraZeneca at 38 sites in 8 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 4 inclusion and 3 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany, Hungary, Norway, France, Romania and 3 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment (time frame: Twice daily during the last seven days on treatment). 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 NCT00394472, 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 18 Mar 2013.