Trial Outcomes & Findings for Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients (NCT NCT00394472)
NCT ID: NCT00394472
Last Updated: 2013-03-18
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 Disease Questionnaire (RDQ) diary
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
Twice daily during the last seven days on treatment
Results posted on
2013-03-18
Participant Flow
Participant milestones
| Measure |
AZD3355
AZD3355 capsules 65 mg bid
|
Placebo
Placebo capsules bid
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
113
|
111
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
AZD3355
AZD3355 capsules 65 mg bid
|
Placebo
Placebo capsules bid
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
incorrect enrolment
|
4
|
2
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Baseline characteristics by cohort
| Measure |
AZD3355
n=122 Participants
AZD3355 capsules 65 mg bid
|
Placebo
n=122 Participants
Placebo capsules bid
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.1 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
48.7 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
49.9 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Twice daily during the last seven days on 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 Disease Questionnaire (RDQ) diary
Outcome measures
| Measure |
AZD3355
n=114 Participants
AZD3355 capsules 65 mg bid
|
Placebo
n=118 Participants
Placebo capsules bid
|
|---|---|---|
|
Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: An interval of one to two hours after the first intake of AZD3355 65 mg capsuleOutcome measures
| Measure |
AZD3355
n=122 Participants
AZD3355 capsules 65 mg bid
|
Placebo
Placebo capsules bid
|
|---|---|---|
|
Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule
|
0.96 μmol/L
Standard Deviation 0.74
|
—
|
Adverse Events
AZD3355
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3355
AZD3355 capsules 65 mg bid
|
Placebo
Placebo capsules bid
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.82%
1/122
|
0.00%
0/122
|
|
Infections and infestations
Appendicitis
|
0.82%
1/122
|
0.00%
0/122
|
Other adverse events
| Measure |
AZD3355
AZD3355 capsules 65 mg bid
|
Placebo
Placebo capsules bid
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
10.7%
13/122
|
3.3%
4/122
|
|
Gastrointestinal disorders
NAUSEA
|
7.4%
9/122
|
3.3%
4/122
|
|
General disorders
FATIGUE
|
5.7%
7/122
|
5.7%
7/122
|
|
Nervous system disorders
PARAESTHESIA
|
8.2%
10/122
|
4.9%
6/122
|
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 before publ.
- Publication restrictions are in place
Restriction type: OTHER