Gastroesophageal Reflux DiseasePhase 2NCT01043185

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

A Phase 2 study testing AZD3355 in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in United States.

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 the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastroesophageal Reflux Disease
What is being tested?: AZD3355
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Dec 2009to May 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

Provide informed consent
History of GERD with persistent symptoms despite treatment with PPI
Otherwise normal physical health

Who cannot join

History of GERD with symptoms that has not improved at all during treatment with PPI
Prior surgery of the upper gastrointestinal tract
History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Oklahoma City, Oklahoma

Other trials in United States

About this study

Official title: A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

Conditions: Gastroesophageal Reflux Disease
Being tested: AZD3355, placebo
Keywords: GERD, lesogaberan, impedance, pH, pharmacokinetics, safety, tolerability
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD3355Drug
30 mg orally in the morning and 30 mg in the evening for 1 day
AZD3355Drug
90 mg orally in the morning and 90 mg in the evening for 1 day
AZD3355Drug
120 mg orally in the morning and 120 mg in the evening for 1 day
AZD3355Drug
240 mg orally in the morning and 240 mg in the evening for 1 day
placeboDrug
Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Study groups in NCT01043185
Study group	Role	What they receive
A	Experimental	AZD3355 30 mg Receives: Drug: AZD3355
B	Experimental	AZD3355 90 mg Receives: Drug: AZD3355
C	Experimental	AZD3355 120 mg Receives: Drug: AZD3355
D	Experimental	AZD3355 240 mg Receives: Drug: AZD3355
E	Placebo comparator	Placebo Receives: Drug: placebo

What is being measured

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

Total Number of Reflux Episodes During 24 Hours
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)
Measured: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Secondary outcomes (3)

Number of Acid Reflux Episodes
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.
Measured: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Acidic Reflux Episodes
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
Measured: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Alkaline Reflux Episodes
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.
Measured: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Timeline

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

Dec 2009May 2010

First posted6 Jan 2010 (estimated)
Study startDec 2009
Primary completionMay 2010
Study completionMay 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 (1)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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01043185
Sponsor's protocol ID: D9120C00032
Status last verified: May 2011
First submitted: 22 Dec 2009
Last updated: 14 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J. Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study. BMC Gastroenterol. 2014 Nov 18;14:188. doi: 10.1186/1471-230X-14-188.
PubMed 25407279

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

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All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment
ClinicalTrials.gov ID: NCT01043185
Acronym / sponsor ID: D9120C00032
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD, lesogaberan, impedance, pH, pharmacokinetics, safety, tolerability
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 6 Jan 2010 (estimated)
Results: Posted 14 Jun 2011

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: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
A	Experimental	Drug: AZD3355AZD3355 30 mg
B	Experimental	Drug: AZD3355AZD3355 90 mg
C	Experimental	Drug: AZD3355AZD3355 120 mg
D	Experimental	Drug: AZD3355AZD3355 240 mg
E	Placebo comparator	Drug: placeboPlacebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provide informed consent
History of GERD with persistent symptoms despite treatment with PPI
Otherwise normal physical health

Key exclusion criteria (3 listed)

History of GERD with symptoms that has not improved at all during treatment with PPI
Prior surgery of the upper gastrointestinal tract
History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

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
AZD335530 mg orally in the morning and 30 mg in the evening for 1 day	Drug	A
AZD335590 mg orally in the morning and 90 mg in the evening for 1 day	Drug	B
AZD3355120 mg orally in the morning and 120 mg in the evening for 1 day	Drug	C
AZD3355240 mg orally in the morning and 240 mg in the evening for 1 day	Drug	D
placeboPlacebo capsules orally in the morning and placebo capsules in the evening for 1 day	Drug	E

Primary outcome

Total Number of Reflux Episodes During 24 Hours
Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

3 secondary outcomes

Number of Acid Reflux Episodes
Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Acidic Reflux Episodes
Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of Weakly Alkaline Reflux Episodes
Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between

Results and safety

Results posted to the registry on 14 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First 30mg, Then 90mg, Then 120mg, Then Placebo	3	3
First 30mg, Then 90mg, Then Placebo, Then 120mg	2	2
First 120mg, Then Placebo, Then 240mg, Then 90mg	3	3
First Placebo, Then 30mg, Then 90mg, Then 120mg	2	2
First 90mg, Then Placebo, Then 120mg, Then 240mg	2	2
First Placebo, Then 240mg, Then 90mg, Then 30mg	3	3
First 90mg, Then 120mg, Then Placebo, Then 240mg	3	3
First 120mg, Then 30mg, Then 240mg, Then Placebo	3	3
First 240mg, Then 30mg, Then 90mg, Then Placebo	3	3
First Placebo, Then 120mg, Then 30mg, Then 240mg	3	3

Primary outcome: Total Number of Reflux Episodes During 24 Hours

Time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between. Geometric mean (95% Confidence Interval). Unit: Episodes

Measure	AZD3355 30 mg n = 18	AZD3355 90 mg n = 17	AZD3355 120 mg n = 20	AZD3355 240 mg n = 18	Placebo n = 24
Value	59.4 (49.1 to 71.8)	50.7 (41.8 to 61.4)	44.3 (36.9 to 53.2)	38.0 (31.4 to 46.0)	80.5 (67.5 to 96.1)

Population analysed: Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.

3 secondary outcomes are 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 30 mg	0 of 19 (0%)	0 of 19 (0%)	Not reported
AZD3355 90 mg	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
AZD3355 120 mg	0 of 21 (0%)	0 of 21 (0%)	Not reported
AZD3355 240 mg	1 of 20 (5%)	3 of 20 (15%)	Not reported
Placebo	0 of 26 (0%)	2 of 26 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25407279Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J. Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study. BMC Gastroenterol. 2014 Nov 18;14:188. doi: 10.1186/1471-230X-14-188.

Related trials for Gastroesophageal Reflux Disease

Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
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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.

Philip Miner principal investigator

Oklahoma Foundation of Digestive Research

Debra G Silberg study director

AstraZeneca

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 AZD3355 in people with Gastroesophageal Reflux Disease, 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 14 Jun 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 14 Jun 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?

Total Number of Reflux Episodes During 24 Hours (time frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between). 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 NCT01043185, 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 14 Jun 2011.