Trial Outcomes & Findings for A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease (NCT NCT00165646)
NCT ID: NCT00165646
Last Updated: 2011-07-18
Results Overview
"Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
4 weeks
Results posted on
2011-07-18
Participant Flow
This study was recruited at 35 centers in Japan during the period of Sep-2004 to Oct-2005.
Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid were transferred to treatment period (randomized double-blind) of placebo, E3810 5 or 10 mg/day for four weeks.
Participant milestones
| Measure |
Placebo
once daily orally for 4 weeks
|
E3810 5 mg
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
93
|
102
|
|
Overall Study
COMPLETED
|
88
|
88
|
98
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
once daily orally for 4 weeks
|
E3810 5 mg
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=91 Participants
once daily orally for 4 weeks
|
E3810 5 mg
n=93 Participants
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
n=101 Participants
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
49.7 years
STANDARD_DEVIATION 17.0 • n=39 Participants
|
46.3 years
STANDARD_DEVIATION 15.3 • n=41 Participants
|
46.8 years
STANDARD_DEVIATION 15.7 • n=35 Participants
|
47.6 years
STANDARD_DEVIATION 16.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=39 Participants
|
55 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
157 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
128 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
91 Participants
n=39 Participants
|
93 Participants
n=41 Participants
|
101 Participants
n=35 Participants
|
285 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
91 participants
n=39 Participants
|
93 participants
n=41 Participants
|
101 participants
n=35 Participants
|
285 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS).
"Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days
Outcome measures
| Measure |
Placebo
n=91 Participants
once daily orally for 4 weeks
|
E3810 5 mg
n=93 Participants
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
n=101 Participants
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
|---|---|---|---|
|
Percentage of Participants With Complete Relief of Heartburn at Final Evaluation
|
20.9 Percentage of participants
|
34.4 Percentage of participants
|
43.6 Percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
E3810 5 mg
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
E3810 10 mg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=91 participants at risk
once daily orally for 4 weeks
|
E3810 5 mg
n=93 participants at risk
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
n=102 participants at risk
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/91
|
1.1%
1/93
|
0.00%
0/102
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/91
|
1.1%
1/93
|
0.00%
0/102
|
Other adverse events
| Measure |
Placebo
n=91 participants at risk
once daily orally for 4 weeks
|
E3810 5 mg
n=93 participants at risk
E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
|
E3810 10 mg
n=102 participants at risk
E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.9%
9/91 • Number of events 9
|
6.5%
6/93 • Number of events 7
|
3.9%
4/102 • Number of events 4
|
|
Infections and infestations
Cystitis
|
0.00%
0/91
|
0.00%
0/93
|
2.0%
2/102 • Number of events 3
|
|
Infections and infestations
Bronchitis acute
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Infections and infestations
Influenza
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Infections and infestations
Orchitis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
2.0%
2/102 • Number of events 2
|
|
Nervous system disorders
Headache
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
2.0%
2/102 • Number of events 3
|
|
Nervous system disorders
Migraine
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
Paraesthesia oral
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Eye disorders
Dry eye
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Cardiac disorders
Palpitations
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Vascular disorders
Haemorrhage subcutaneous
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/91
|
5.4%
5/93 • Number of events 5
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal discomfort
|
3.3%
3/91 • Number of events 3
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
2/91 • Number of events 2
|
2.2%
2/93 • Number of events 2
|
2.9%
3/102 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
4/91 • Number of events 4
|
1.1%
1/93 • Number of events 1
|
2.0%
2/102 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
3.9%
4/102 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/91 • Number of events 3
|
0.00%
0/93
|
2.9%
3/102 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/91
|
3.2%
3/93 • Number of events 3
|
0.00%
0/102
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
2.0%
2/102 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/91 • Number of events 2
|
0.00%
0/93
|
0.00%
0/102
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/91 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/91
|
3.2%
3/93 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Early satiety
|
2.2%
2/91 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
2.9%
3/102 • Number of events 3
|
|
General disorders
Malaise
|
2.2%
2/91 • Number of events 2
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/91
|
2.2%
2/93 • Number of events 2
|
0.00%
0/102
|
|
General disorders
Thirst
|
0.00%
0/91
|
2.2%
2/93 • Number of events 2
|
0.00%
0/102
|
|
General disorders
Chest pain
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.98%
1/102 • Number of events 2
|
|
General disorders
Chest discomfort
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.2%
2/91 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/91 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
0.00%
0/102
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Investigations
Blood triglycerides increased
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Investigations
Neutrophil count increased
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Blood urea increased
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Investigations
C-reactive protein increased
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/91
|
0.00%
0/93
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/102
|
Additional Information
Nobuyuki Sugisaki, Study Director
Eisai Co.,Ltd. Eisai Product Creation Systems
Phone: +81-3-3817-3908
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place