GERDPhase 2C27NCT00703534

Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

A Phase 2 study testing AZD3355 and Gelusil® in people with GERD and Acid Reflux Disease, run by AstraZeneca at 84 sites 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

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: GERD, Acid Reflux Disease, Heartburn
What is being tested?: AZD3355 and Gelusil®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 478 participants
Where: 84 sitesUnited States
Study dates: May 2008to Jan 2009
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

Subject able to read and write US english and able to use electronic devices
Subjects who have experienced GERD symptoms for at least six months
Subjects currently taking a prescription or over-the-counter PPI medications for GERD
Body Mass Index (BMI) 18.5-35.0, inclusive

Who cannot join

Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
Subjects 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
Prior surgery of the upper Gastrointestinal (GI) tract

Trial locations and contacts

84 sites in 1 country.

City, postcode or hospital

84 sites in 1 country

United States84 sites

Research Site
Akron, Ohio
Research Site
Anaheim, California
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Anderson, South Carolina
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Arkansas City, Kansas
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Asheville, North Carolina
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Athens, Alabama
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Atlanta, Georgia
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Baltimore, Maryland
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Biloxi, Mississippi
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Boynton Beach, Florida
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Brockton, Massachusetts
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Canton, Ohio
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Charlottesville, Virginia
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Chattanooga, Tennessee
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Chesapeake, Virginia
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Chesterfield, Michigan
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Chevy Chase, Maryland
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Chicago, Illinois
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Christiansburg, Virginia
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Colorado Springs, Colorado
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Columbia, Maryland
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Cranston, Rhode Island
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DeLand, Florida
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Duncansville, Pennsylvania
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Elkin, North Carolina
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Elkridge, Maryland
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Fayetteville, North Carolina
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Germantown, Tennessee
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Great Neck, New York
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Greensboro, North Carolina
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Harrisburg, North Carolina
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Harrisburg, Pennsylvania
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Hialeah, Florida
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Hollywood, Maryland
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Houston, Texas
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Jackson, Mississippi
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Jackson, Tennessee
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Jacksonville, Florida
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Jefferson City, Missouri
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Johnson City, Tennessee
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Jupiter, Florida
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Knoxville, Tennessee
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Las Vegas, Nevada
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Lauderdale Lakes, Florida
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Little Rock, Arkansas
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Los Angeles, California
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Madisonville, Kentucky
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Miami, Florida
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Milwaukee, Wisconsin
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Monroe, Louisiana
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Monterey, California
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Morgantown, North Carolina
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Murrieta, California
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Nashville, Tennessee
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New Smyrna Beach, Florida
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New York, New York
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Newport News, Virginia
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Newton, Kansas
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Norfolk, Virginia
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Norman, Oklahoma
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Ogden, Utah
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Oklahoma City, Oklahoma
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Orange, California
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Pembroke Pines, Florida
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Port Orange, Florida
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Portland, Oregon
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Pueblo, Colorado
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Richmond, Virginia
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San Antonio, Texas
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San Diego, California
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Sayre, Pennsylvania
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Sherwood, Arkansas
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Shreveport, Louisiana
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Simpsonville, South Carolina
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Stockbridge, Georgia
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Tampa, Florida
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Torrance, California
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Tucson, Arizona
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Waukesha, Wisconsin
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West End, Wisconsin
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Wichita, Kansas
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Zephyrhills, Florida

Other trials in United States

About this study

Official title: Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Conditions: GERD, Acid Reflux Disease, Heartburn, Regurgitation
Being tested: AZD3355, Placebo, Gelusil®
Keywords: GERD, Acid Reflux, Heartburn, Regurgitation, non-acid reflux, PRO measures
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
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
PlaceboDrug
capsule. administered as a single dose twice daily for 4 weeks
Gelusil®Drug
Chewable tablets taken as needed

Study groups in NCT00703534
Study group	Role	What they receive
AZD3355	Experimental	Not described Receives: Drug: AZD3355; Drug: Gelusil®
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Gelusil®

What is being measured

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

Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Measured: Run-in period of 8-12 days and treatment period of 26-30 days

Timeline

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

May 2008Jan 2009

First posted23 Jun 2008 (estimated)
Study startMay 2008
Primary completionJan 2009
Study completionJan 2009

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 (3)Papers the sponsor has linked to this study.
Other trials for GERDStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00703534
Sponsor's protocol ID: D9120C00027
Acronym: C27
Status last verified: May 2011
First submitted: 19 Jun 2008
Last updated: 20 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ryden A, Leavy OC, Halling K, Stone AA. Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy. Value Health. 2016 Sep-Oct;19(6):829-833. doi: 10.1016/j.jval.2016.05.007. Epub 2016 Jun 29.
PubMed 27712711
Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177.
PubMed 25304129
Ryden A, Denison H, Karlsson M, Vakil N. Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors. Scand J Gastroenterol. 2013 Sep;48(9):1018-26. doi: 10.3109/00365521.2013.822544. Epub 2013 Aug 6.
PubMed 23919738

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 GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period
ClinicalTrials.gov ID: NCT00703534
Acronym / sponsor ID: C27 / D9120C00027
Conditions: GERD, Acid Reflux Disease, Heartburn, Regurgitation
Keywords: GERD, Acid Reflux, Heartburn, Regurgitation, non-acid reflux, PRO measures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 478 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 23 Jun 2008 (estimated)
Results: Posted 20 Jun 2011

Clinical summary

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

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD3355	Experimental	Drug: AZD3355, Drug: Gelusil®
Placebo	Placebo comparator	Drug: Placebo, Drug: Gelusil®

Who may qualify

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

Key inclusion criteria (4 listed)

Subject able to read and write US english and able to use electronic devices
Subjects who have experienced GERD symptoms for at least six months
Subjects currently taking a prescription or over-the-counter PPI medications for GERD
Body Mass Index (BMI) 18.5-35.0, inclusive

Key exclusion criteria (3 listed)

Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
Subjects 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
Prior surgery of the upper Gastrointestinal (GI) tract

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: LesogaberanImmediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks	Drug	AZD3355
Placebocapsule. administered as a single dose twice daily for 4 weeks	Drug	Placebo
Gelusil®Chewable tablets taken as needed	Drug	AZD3355, Placebo

Primary outcome

Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
Time frame: Run-in period of 8-12 days and treatment period of 26-30 days
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)

Results and safety

Results posted to the registry on 20 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
AZD3355	235	205
Placebo	243	218

Primary outcome: Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary

Time frame: Run-in period of 8-12 days and treatment period of 26-30 days. Number. Unit: participants

Population analysed: None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD3355	1 of ?	18 of ?	Not reported
Placebo	2 of ?	7 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27712711Ryden A, Leavy OC, Halling K, Stone AA. Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy. Value Health. 2016 Sep-Oct;19(6):829-833. doi: 10.1016/j.jval.2016.05.007. Epub 2016 Jun 29.
Derived from this study: PubMed 25304129Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177.
Derived from this study: PubMed 23919738Ryden A, Denison H, Karlsson M, Vakil N. Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors. Scand J Gastroenterol. 2013 Sep;48(9):1018-26. doi: 10.3109/00365521.2013.822544. Epub 2013 Aug 6.

Related trials for 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.

Debra Silberg, MD study director

AstraZeneca

Nimish Vakil, MD principal investigator

Aurora Health Center/Waukesha

84 sites 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 and Gelusil® in people with GERD and Acid Reflux Disease, run by AstraZeneca at 84 sites 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 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 20 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 84 sites 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 20 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?

Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary (time frame: Run-in period of 8-12 days and treatment period of 26-30 days). 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 NCT00703534, which also lists 3 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 20 Jun 2011.