Trial · NCT01043185

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

NCT01043185, Phase 2, Completed, AstraZeneca; results first posted 2011-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience. Trials, record NCT01043185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01043185

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
NCT number: NCT01043185
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: AstraZeneca
Conditions: Gastroesophageal Reflux Disease
Interventions: AZD3355, AZD3355, AZD3355, AZD3355, placebo
First posted: 2010-01-06
Last updated: 2011-06-14
Results first posted: 2011-06-14

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Number of Reflux Episodes During 24 Hours	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)
Secondary	Number of Acid Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.
Secondary	Number of Weakly Acidic Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
Secondary	Number of Weakly Alkaline Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Number of Reflux Episodes During 24 Hours	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.	Episodes	GEOMETRIC_MEAN
SECONDARY	Number of Acid Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.	Episodes	GEOMETRIC_MEAN
SECONDARY	Number of Weakly Acidic Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.	Episodes	GEOMETRIC_MEAN
SECONDARY	Number of Weakly Alkaline Reflux Episodes	Measured during 24 hours at 4 different visits with a 7-28 days interval between	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.	Episodes	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Number of Reflux Episodes During 24 Hours	AZD3355 30 mg	59.4	95% Confidence Interval 49.1 to 71.8	Episodes
Total Number of Reflux Episodes During 24 Hours	AZD3355 90 mg	50.7	95% Confidence Interval 41.8 to 61.4	Episodes
Total Number of Reflux Episodes During 24 Hours	AZD3355 120 mg	44.3	95% Confidence Interval 36.9 to 53.2	Episodes
Total Number of Reflux Episodes During 24 Hours	AZD3355 240 mg	38.0	95% Confidence Interval 31.4 to 46.0	Episodes
Total Number of Reflux Episodes During 24 Hours	Placebo	80.5	95% Confidence Interval 67.5 to 96.1	Episodes
Number of Acid Reflux Episodes	AZD3355 30 mg	9.6	95% Confidence Interval 4.9 to 18.8	Episodes
Number of Acid Reflux Episodes	AZD3355 90 mg	8.0	95% Confidence Interval 4.1 to 15.8	Episodes
Number of Acid Reflux Episodes	AZD3355 120 mg	6.2	95% Confidence Interval 3.2 to 12.0	Episodes
Number of Acid Reflux Episodes	AZD3355 240 mg	6.3	95% Confidence Interval 3.2 to 12.4	Episodes
Number of Acid Reflux Episodes	Placebo	14.7	95% Confidence Interval 7.7 to 28.0	Episodes

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow210

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 - First Intervention	STARTED	First 30mg, Then 90mg, Then 120mg, Then Placebo	3
Period 1 - First Intervention	STARTED	First 30mg, Then 90mg, Then Placebo, Then 120mg	2
Period 1 - First Intervention	STARTED	First 120mg, Then Placebo, Then 240mg, Then 90mg	3
Period 1 - First Intervention	STARTED	First Placebo, Then 30mg, Then 90mg, Then 120mg	2
Period 1 - First Intervention	STARTED	First 90mg, Then Placebo, Then 120mg, Then 240mg	2
Period 1 - First Intervention	STARTED	First Placebo, Then 240mg, Then 90mg, Then 30mg	3
Period 1 - First Intervention	STARTED	First 90mg, Then 120mg, Then Placebo, Then 240mg	3
Period 1 - First Intervention	STARTED	First 120mg, Then 30mg, Then 240mg, Then Placebo	3
Period 1 - First Intervention	STARTED	First 240mg, Then 30mg, Then 90mg, Then Placebo	3
Period 1 - First Intervention	STARTED	First Placebo, Then 120mg, Then 30mg, Then 240mg	3

1 to 10 of 210Source ClinicalTrials.gov

See all 210 participant flow

Adverse events35

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Gastroenteritisviral	Infections and infestations	AZD3355 30 mg	0	19
other	Gastroenteritisviral	Infections and infestations	AZD3355 90 mg	0	21
other	Gastroenteritisviral	Infections and infestations	AZD3355 120 mg	0	21
other	Gastroenteritisviral	Infections and infestations	AZD3355 240 mg	0	20
other	Gastroenteritisviral	Infections and infestations	Placebo	2	26
other	Sinusitis	Infections and infestations	AZD3355 30 mg	0	19
other	Sinusitis	Infections and infestations	AZD3355 90 mg	0	21
other	Sinusitis	Infections and infestations	AZD3355 120 mg	0	21
other	Sinusitis	Infections and infestations	AZD3355 240 mg	1	20
other	Sinusitis	Infections and infestations	Placebo	0	26

1 to 10 of 35Source ClinicalTrials.gov

See all 35 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZD3355 30 mg
Total, all-cause mortality	AZD3355 90 mg
Total, all-cause mortality	AZD3355 120 mg
Total, all-cause mortality	AZD3355 240 mg
Total, all-cause mortality	Placebo
Total, other adverse events	AZD3355 30 mg	0	19
Total, other adverse events	AZD3355 90 mg	1	21
Total, other adverse events	AZD3355 120 mg	0	21
Total, other adverse events	AZD3355 240 mg	3	20
Total, other adverse events	Placebo	2	26

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25407279	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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