Trial Outcomes & Findings for A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg (NCT NCT00464308)
NCT ID: NCT00464308
Last Updated: 2014-04-21
Results Overview
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1392 participants
Primary outcome timeframe
week 4 of treatment
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
Rabeprazole 20 mg/Day
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
464
|
469
|
459
|
|
Overall Study
COMPLETED
|
395
|
406
|
400
|
|
Overall Study
NOT COMPLETED
|
69
|
63
|
59
|
Reasons for withdrawal
| Measure |
Rabeprazole 20 mg/Day
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
22
|
27
|
16
|
|
Overall Study
Lost to Follow-up
|
29
|
19
|
20
|
|
Overall Study
Patient discontinued and other reasons
|
17
|
17
|
23
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg
Baseline characteristics by cohort
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Total
n=1392 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
48 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
620 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
772 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
464 participants
n=5 Participants
|
469 participants
n=7 Participants
|
459 participants
n=5 Participants
|
1392 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 4 of treatmentPopulation: The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Number of Patients With Complete Resolution of Heartburn by Week 4
|
272 participants
|
302 participants
|
278 participants
|
PRIMARY outcome
Timeframe: 4 weeksComplete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
|
281 participants
|
283 participants
|
276 participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
|
405 participants
|
418 participants
|
414 participants
|
PRIMARY outcome
Timeframe: 4 weeksSatisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
|
397 participants
|
413 participants
|
402 participants
|
SECONDARY outcome
Timeframe: week 4 of treatmentPopulation: ITT population
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Median Time to Complete Resolution of Heartburn Symptoms.
|
11 days
Interval 9.0 to 15.0
|
9 days
Interval 7.0 to 10.0
|
12 days
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT population
Outcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Median Time to Complete Relief of Regurgitation Symptoms
|
9 days
Interval 7.0 to 12.0
|
11 days
Interval 8.0 to 14.0
|
13 days
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Rabeprazole 20 mg/Day
n=464 Participants
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 Participants
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 Participants
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
|
56.3 percent of participants
Interval 53.1 to 59.5
|
63.4 percent of participants
Interval 60.2 to 66.6
|
56.1 percent of participants
Interval 52.9 to 59.3
|
Adverse Events
Rabeprazole 20 mg/Day
Serious events: 5 serious events
Other events: 151 other events
Deaths: 0 deaths
Esomeprazole 40 mg/Day
Serious events: 1 serious events
Other events: 155 other events
Deaths: 0 deaths
Esomeprazole 20 mg/Day
Serious events: 9 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 20 mg/Day
n=464 participants at risk
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 participants at risk
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 participants at risk
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
meniscal tear of right knee
|
0.22%
1/464 • Number of events 1
|
0.00%
0/469
|
0.00%
0/459
|
|
Hepatobiliary disorders
cholecystitis
|
0.22%
1/464 • Number of events 1
|
0.00%
0/469
|
0.00%
0/459
|
|
Infections and infestations
lower respiratory tract infection
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Infections and infestations
pneumonia
|
0.22%
1/464 • Number of events 1
|
0.00%
0/469
|
0.00%
0/459
|
|
Social circumstances
alleged assault
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
General disorders
chest pain
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
0.22%
1/464 • Number of events 1
|
0.00%
0/469
|
0.00%
0/459
|
|
Cardiac disorders
angina unstable
|
0.00%
0/464
|
0.21%
1/469 • Number of events 1
|
0.00%
0/459
|
|
General disorders
fever
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Surgical and medical procedures
perianal abscess drainage
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
multiple pulmonary embolism
|
0.22%
1/464 • Number of events 1
|
0.00%
0/469
|
0.00%
0/459
|
|
Psychiatric disorders
depression
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
|
Vascular disorders
hypotension
|
0.00%
0/464
|
0.00%
0/469
|
0.22%
1/459 • Number of events 1
|
Other adverse events
| Measure |
Rabeprazole 20 mg/Day
n=464 participants at risk
Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 40 mg/Day
n=469 participants at risk
Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
Esomeprazole 20 mg/Day
n=459 participants at risk
Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal motility and defaecation cond
|
5.2%
24/464 • Number of events 26
|
6.2%
29/469 • Number of events 32
|
7.8%
36/459 • Number of events 40
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
13.6%
63/464 • Number of events 86
|
14.3%
67/469 • Number of events 80
|
11.8%
54/459 • Number of events 77
|
|
Gastrointestinal disorders
Salivary gland conditions
|
0.43%
2/464 • Number of events 4
|
1.7%
8/469 • Number of events 8
|
0.87%
4/459 • Number of events 7
|
|
Infections and infestations
Infections - pathogen class unspecified
|
4.5%
21/464 • Number of events 22
|
1.9%
9/469 • Number of events 10
|
5.7%
26/459 • Number of events 29
|
|
Infections and infestations
Viral infectious disorders
|
1.9%
9/464 • Number of events 9
|
1.3%
6/469 • Number of events 7
|
2.8%
13/459 • Number of events 13
|
|
Infections and infestations
Other
|
0.43%
2/464 • Number of events 2
|
0.21%
1/469 • Number of events 1
|
0.00%
0/459
|
|
Musculoskeletal and connective tissue disorders
Joint disorders
|
0.43%
2/464 • Number of events 2
|
1.7%
8/469 • Number of events 8
|
0.65%
3/459 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle disorders
|
0.86%
4/464 • Number of events 4
|
0.43%
2/469 • Number of events 2
|
0.87%
4/459 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders NEC
|
1.5%
7/464 • Number of events 7
|
1.7%
8/469 • Number of events 8
|
1.3%
6/459 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.22%
1/464 • Number of events 1
|
0.21%
1/469 • Number of events 1
|
0.00%
0/459
|
|
Nervous system disorders
Headaches
|
4.1%
19/464 • Number of events 22
|
5.1%
24/469 • Number of events 30
|
6.8%
31/459 • Number of events 32
|
|
Nervous system disorders
Neurological disorders NEC
|
1.9%
9/464 • Number of events 9
|
1.9%
9/469 • Number of events 10
|
2.4%
11/459 • Number of events 11
|
Additional Information
Executive Director, Medical & Scientific Affairs
Janssen-Cilag Pty Ltd
Phone: +61 2 9815 3219
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60