Trial Outcomes & Findings for Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI (NCT NCT01005251)
NCT ID: NCT01005251
Last Updated: 2011-04-25
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
661 participants
Primary outcome timeframe
The 7 days before randomisation (baseline) and during 26-30 days of treatment
Results posted on
2011-04-25
Participant Flow
Participant milestones
| Measure |
AZD3355 60 mg
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
PPI+Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
134
|
125
|
136
|
126
|
140
|
|
Overall Study
COMPLETED
|
121
|
109
|
114
|
114
|
122
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
22
|
12
|
18
|
Reasons for withdrawal
| Measure |
AZD3355 60 mg
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
PPI+Placebo
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
3
|
4
|
9
|
|
Overall Study
Eligibility criteria not fulfilled
|
4
|
0
|
4
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
6
|
8
|
5
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Developed study-specific withdrawal crit
|
2
|
0
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Patient moved
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Wrong drug dispensed
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized in error
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Baseline characteristics by cohort
| Measure |
AZD3355 60 mg
n=134 Participants
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
n=125 Participants
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
n=136 Participants
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
n=126 Participants
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
n=140 Participants
PPI+Placebo
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
47.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
48.3 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
47.7 years
STANDARD_DEVIATION 12.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
376 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
285 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: The 7 days before randomisation (baseline) and during 26-30 days of treatmentSymptom 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)
Outcome measures
| Measure |
AZD3355 60 mg
n=134 Participants
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
n=125 Participants
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
n=136 Participants
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
n=126 Participants
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
n=140 Participants
PPI+Placebo
|
|---|---|---|---|---|---|
|
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)
|
28 Participants
|
32 Participants
|
32 Participants
|
33 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: The 7 days before randomisation (baseline) and during 26-30 days of treatmentSymptom 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)
Outcome measures
| Measure |
AZD3355 60 mg
n=132 Participants
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
n=117 Participants
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
n=133 Participants
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
n=123 Participants
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
n=135 Participants
PPI+Placebo
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
|
10.7 Percent
Interval 0.0 to 35.7
|
17.2 Percent
Interval 0.0 to 46.4
|
11.9 Percent
Interval 0.0 to 40.9
|
12.5 Percent
Interval 0.0 to 47.1
|
0 Percent
Interval 0.0 to 30.8
|
Adverse Events
AZD3355 60 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
AZD3355 120 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
AZD3355 180 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AZD3355 240 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3355 60 mg
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
PPI+Placebo
|
|---|---|---|---|---|---|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/135
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/124
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/136
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.79%
1/126
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/140
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Gastric Cancer
|
0.00%
0/135
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/124
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/136
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.00%
0/126
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.71%
1/140
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
Other adverse events
| Measure |
AZD3355 60 mg
PPI+AZD3355 60 mg twice daily (bid)
|
AZD3355 120 mg
PPI+AZD3355 120 mg twice daily (bid)
|
AZD3355 180 mg
PPI+AZD3355 180 mg twice daily (bid)
|
AZD3355 240 mg
PPI+AZD3355 240 mg twice daily (bid)
|
Placebo
PPI+Placebo
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
5/135
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
5.6%
7/124
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
4.4%
6/136
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
7.9%
10/126
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
0.71%
1/140
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
8/135
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
4.0%
5/124
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
7.4%
10/136
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
8.7%
11/126
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
5.7%
8/140
As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
|
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