Trial Outcomes & Findings for A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience (NCT NCT01043185)
NCT ID: NCT01043185
Last Updated: 2011-06-14
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Measured during 24 hours at 4 different visits with a 7-28 days interval between
Results posted on
2011-06-14
Participant Flow
Participant milestones
| Measure |
First 30mg, Then 90mg, Then 120mg, Then Placebo
Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
|
First 30mg, Then 90mg, Then Placebo, Then 120mg
Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
|
First 120mg, Then Placebo, Then 240mg, Then 90mg
Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
|
First Placebo, Then 30mg, Then 90mg, Then 120mg
Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
|
First 90mg, Then Placebo, Then 120mg, Then 240mg
Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
First Placebo, Then 240mg, Then 90mg, Then 30mg
Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
|
First 90mg, Then 120mg, Then Placebo, Then 240mg
Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
First 120mg, Then 30mg, Then 240mg, Then Placebo
Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
|
First 240mg, Then 30mg, Then 90mg, Then Placebo
Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
|
First Placebo, Then 120mg, Then 30mg, Then 240mg
Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 - First Intervention
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 1 - First Intervention
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 1 - First Intervention
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2 - First Washout Period
STARTED
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3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 2 - First Washout Period
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 2 - First Washout Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3 - Second Intervention
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 3 - Second Intervention
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 3 - Second Intervention
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4 - Second Washout Period
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 4 - Second Washout Period
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 4 - Second Washout Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 5 - Third Intervention
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 5 - Third Intervention
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 5 - Third Intervention
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 6 - Third Washout Period
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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3
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3
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Period 6 - Third Washout Period
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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2
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3
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Period 6 - Third Washout Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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Period 7 - Fourth Intervention
STARTED
|
3
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2
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3
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2
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2
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3
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3
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3
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2
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3
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Period 7 - Fourth Intervention
COMPLETED
|
3
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2
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3
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2
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2
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3
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3
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3
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2
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3
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Period 7 - Fourth Intervention
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
First 30mg, Then 90mg, Then 120mg, Then Placebo
Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
|
First 30mg, Then 90mg, Then Placebo, Then 120mg
Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
|
First 120mg, Then Placebo, Then 240mg, Then 90mg
Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
|
First Placebo, Then 30mg, Then 90mg, Then 120mg
Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
|
First 90mg, Then Placebo, Then 120mg, Then 240mg
Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
First Placebo, Then 240mg, Then 90mg, Then 30mg
Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
|
First 90mg, Then 120mg, Then Placebo, Then 240mg
Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
First 120mg, Then 30mg, Then 240mg, Then Placebo
Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
|
First 240mg, Then 30mg, Then 90mg, Then Placebo
Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
|
First Placebo, Then 120mg, Then 30mg, Then 240mg
Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 6 - Third Washout Period
Protocol Violation
|
0
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0
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0
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0
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0
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0
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0
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0
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1
|
0
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Baseline Characteristics
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=27 Participants
Includes all groups randomized to one of 10 sequences of drug or placebo.
|
|---|---|
|
Age Continuous
|
43.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured during 24 hours at 4 different visits with a 7-28 days interval betweenPopulation: 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.
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)
Outcome measures
| Measure |
AZD3355 30 mg
n=18 Participants
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=17 Participants
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=20 Participants
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=18 Participants
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=24 Participants
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Total Number of Reflux Episodes During 24 Hours
|
59.4 Episodes
Interval 49.1 to 71.8
|
50.7 Episodes
Interval 41.8 to 61.4
|
44.3 Episodes
Interval 36.9 to 53.2
|
38.0 Episodes
Interval 31.4 to 46.0
|
80.5 Episodes
Interval 67.5 to 96.1
|
SECONDARY outcome
Timeframe: Measured during 24 hours at 4 different visits with a 7-28 days interval betweenPopulation: 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.
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.
Outcome measures
| Measure |
AZD3355 30 mg
n=18 Participants
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=17 Participants
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=20 Participants
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=18 Participants
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=24 Participants
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Number of Acid Reflux Episodes
|
9.6 Episodes
Interval 4.9 to 18.8
|
8.0 Episodes
Interval 4.1 to 15.8
|
6.2 Episodes
Interval 3.2 to 12.0
|
6.3 Episodes
Interval 3.2 to 12.4
|
14.7 Episodes
Interval 7.7 to 28.0
|
SECONDARY outcome
Timeframe: Measured during 24 hours at 4 different visits with a 7-28 days interval betweenPopulation: 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.
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
Outcome measures
| Measure |
AZD3355 30 mg
n=18 Participants
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=17 Participants
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=20 Participants
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=18 Participants
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=24 Participants
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Number of Weakly Acidic Reflux Episodes
|
37.0 Episodes
Interval 27.4 to 49.9
|
35.4 Episodes
Interval 26.2 to 47.8
|
28.7 Episodes
Interval 21.5 to 38.3
|
28.4 Episodes
Interval 21.0 to 38.3
|
51.6 Episodes
Interval 39.0 to 68.2
|
SECONDARY outcome
Timeframe: Measured during 24 hours at 4 different visits with a 7-28 days interval betweenPopulation: 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.
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.
Outcome measures
| Measure |
AZD3355 30 mg
n=18 Participants
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=17 Participants
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=20 Participants
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=18 Participants
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=24 Participants
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Number of Weakly Alkaline Reflux Episodes
|
0 Episodes
Interval 0.0 to 0.0
|
0 Episodes
Interval 0.0 to 1.0
|
0 Episodes
Interval 0.0 to 1.0
|
0 Episodes
Interval 0.0 to 2.0
|
0 Episodes
Interval 0.0 to 1.0
|
Adverse Events
AZD3355 30 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD3355 90 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD3355 120 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD3355 240 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3355 30 mg
n=19 participants at risk
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=21 participants at risk
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=21 participants at risk
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=20 participants at risk
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=26 participants at risk
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
Other adverse events
| Measure |
AZD3355 30 mg
n=19 participants at risk
a morning and an evening dose of AZD3355 30 mg
|
AZD3355 90 mg
n=21 participants at risk
a morning and an evening dose of AZD3355 90 mg
|
AZD3355 120 mg
n=21 participants at risk
a morning and an evening dose of AZD3355 120 mg
|
AZD3355 240 mg
n=20 participants at risk
a morning and an evening dose of AZD3355 240 mg
|
Placebo
n=26 participants at risk
a morning and an evening dose of placebo
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritisviral
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/20
|
7.7%
2/26
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19
|
4.8%
1/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19
|
0.00%
0/21
|
0.00%
0/21
|
5.0%
1/20
|
0.00%
0/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between PI and Sponsor (AZ) or its agents that restricts the PI's right to discuss/publish trial results after the trial is completed.The PI agrees to collaborate in good faith with AZ with regards to content and formation of any publication or disclosure to be made by PI and to pay due consideration to opinions offered by AZ.
- Publication restrictions are in place
Restriction type: OTHER