Gastroesophageal Reflux DiseasePhase 2NCT01005251
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
A Phase 2 study testing lesogaberan (AZD3355) in people with Gastroesophageal Reflux Disease and Heartburn, run by AstraZeneca at 1 site in United States.
Trial summary
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation
- What is being tested?
- lesogaberan (AZD3355)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 661 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Have at least 6 months history of GERD
- Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication
Who cannot join
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Prior surgery of the upper gastrointestinal tract.
- Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
Trial locations and contacts
1 site in 1 country.
About this study
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
- Conditions
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation
- Being tested
- lesogaberan (AZD3355), Placebo
- Keywords
- GERD treatment, Acid and non-acid Reflux, Heartburn, Regurgitation, Add-on treatment to PPI
- 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.
lesogaberan (AZD3355)Drug
60 mg, oral, capsules, bid for 4 w
lesogaberan (AZD3355)Drug
120 mg, oral, capsules, bid for 4 w
lesogaberan (AZD3355)Drug
180 mg, oral, capsules, bid for 4 w
lesogaberan (AZD3355)Drug
240 mg, oral, capsules, bid for 4 w
PlaceboDrug
oral,capsules, bid for 4 w
| Study group | Role | What they receive |
|---|---|---|
| 60 mg | Experimental | PPI+lesogaberan (AZD3355) 60 mg bid Receives: Drug: lesogaberan (AZD3355) |
| 120 mg | Experimental | PPI+lesogaberan (AZD3355) 120 mg bid Receives: Drug: lesogaberan (AZD3355) |
| 180 mg | Experimental | PPI+lesogaberan (AZD3355) 180 mg bid Receives: Drug: lesogaberan (AZD3355) |
| 240 mg | Experimental | PPI+lesogaberan (AZD3355) 240 mg bid Receives: Drug: lesogaberan (AZD3355) |
| Placebo | Placebo comparator | PPI+ Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
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 Symptom Questionnaire diary.
(GERD = Gastroesophageal Reflux Disease)
Measured: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Secondary outcomes (1)
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
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 Symptom Questionnaire diary
(GERD = Gastroesophageal Reflux Disease)
Measured: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
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 (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Debra Silberg, MD, Study director, AstraZenecaNicholas Shaheen, MD, MPH, Principal investigator, UNC Hospitals, 4141Chapel Hill, NC 27599 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005251
- Sponsor's protocol ID
- D9120C00019
- Status last verified
- Mar 2011
- First submitted
- 27 Oct 2009
- Last updated
- 25 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.
PubMed 23318482Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23.
PubMed 22730470
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
- ClinicalTrials.gov ID
- NCT01005251
- Acronym / sponsor ID
- D9120C00019
- Conditions
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation
- Keywords
- GERD treatment, Acid and non-acid Reflux, Heartburn, Regurgitation, Add-on treatment to PPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 25 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 60 mg | Experimental | Drug: lesogaberan (AZD3355)PPI+lesogaberan (AZD3355) 60 mg bid |
| 120 mg | Experimental | Drug: lesogaberan (AZD3355)PPI+lesogaberan (AZD3355) 120 mg bid |
| 180 mg | Experimental | Drug: lesogaberan (AZD3355)PPI+lesogaberan (AZD3355) 180 mg bid |
| 240 mg | Experimental | Drug: lesogaberan (AZD3355)PPI+lesogaberan (AZD3355) 240 mg bid |
| Placebo | Placebo comparator | Drug: PlaceboPPI+ Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Have at least 6 months history of GERD
- Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication
Key exclusion criteria (3 listed)
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Prior surgery of the upper gastrointestinal tract.
- Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
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 |
|---|---|---|
| lesogaberan (AZD3355)60 mg, oral, capsules, bid for 4 w | Drug | 60 mg |
| lesogaberan (AZD3355)120 mg, oral, capsules, bid for 4 w | Drug | 120 mg |
| lesogaberan (AZD3355)180 mg, oral, capsules, bid for 4 w | Drug | 180 mg |
| lesogaberan (AZD3355)240 mg, oral, capsules, bid for 4 w | Drug | 240 mg |
| Placebooral,capsules, bid for 4 w | Drug | Placebo |
Primary outcome
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
Time frame: The 7 days before randomisation (baseline) and during 26-30 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 Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)
1 secondary outcome
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
Time frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23318482Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.
- Derived from this study: PubMed 22730470Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23.
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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.
Debra Silberg, MD study director
AstraZeneca
Nicholas Shaheen, MD, MPH principal investigator
UNC Hospitals, 4141Chapel Hill, NC 27599 USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lesogaberan (AZD3355) in people with Gastroesophageal Reflux Disease and Heartburn, run by AstraZeneca at 1 site in United States.
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 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 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2011). 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 a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) (time frame: The 7 days before randomisation (baseline) and during 26-30 days of 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 NCT01005251, which also lists 2 linked publications.
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 25 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.