Trial Outcomes & Findings for Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (NCT NCT00703534)
NCT ID: NCT00703534
Last Updated: 2011-06-20
Results Overview
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
478 participants
Primary outcome timeframe
Run-in period of 8-12 days and treatment period of 26-30 days
Results posted on
2011-06-20
Participant Flow
Participant milestones
| Measure |
AZD3355
AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
|
Placebo
Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
|
|---|---|---|
|
Overall Study
STARTED
|
235
|
243
|
|
Overall Study
COMPLETED
|
205
|
218
|
|
Overall Study
NOT COMPLETED
|
30
|
25
|
Reasons for withdrawal
| Measure |
AZD3355
AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
|
Placebo
Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Incorrect Enrollment
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Severe Non Compliance
|
1
|
5
|
Baseline Characteristics
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Baseline characteristics by cohort
| Measure |
AZD3355
n=235 Participants
AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
|
Placebo
n=243 Participants
Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49.7 Years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
47.8 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Run-in period of 8-12 days and treatment period of 26-30 daysPopulation: 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.
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Outcome measures
Outcome data not reported
Adverse Events
AZD3355
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3355
AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
|
Placebo
Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
|
|---|---|---|
|
Injury, poisoning and procedural complications
Operative Hemorrhage
|
0.43%
1/235
|
0.00%
0/243
|
|
Psychiatric disorders
Suicide Attemp
|
0.00%
0/235
|
0.41%
1/243
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/235
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/235
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/235
|
0.41%
1/243
|
Other adverse events
| Measure |
AZD3355
AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
|
Placebo
Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
18/235
|
2.9%
7/243
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AZ shall have 30 days from the proposed final manuscript for any disclosure to review it and may within such time require that submission for publication/disclosure be delayed in order for AZ to file patent applications. If study site/investigator requests permission to publish data(incl oral presentations) it is to be agreed with AZ prior to publ.
- Publication restrictions are in place
Restriction type: OTHER