Trial Outcomes & Findings for Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients (NCT NCT00444275)
NCT ID: NCT00444275
Last Updated: 2012-12-11
Results Overview
Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3029 participants
Primary outcome timeframe
16 weeks
Results posted on
2012-12-11
Participant Flow
Patients were recruited by general practitioner between March 1, 2007 and July 21, 2008
The study included 2 phases (maximum treatment duration = 16 weeks): * one initial treatment phase of 4 weeks * one randomized maintenance treatment phase of 12 weeks only for patients whose initial treatment is considered to be successful at the end of the initial phase. Only maintenance phase data were reported in the Baseline module measures.
Participant milestones
| Measure |
Esomeprazole 20 mg Once Daily (Initial Phase)
|
Esomeprazole 40 mg Once Daily (Initial Phase)
|
Esomeprazole 20 mg Once Daily (Maintenance Phase)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Initial Treatment Phase
STARTED
|
2156
|
873
|
0
|
0
|
0
|
|
Initial Treatment Phase
COMPLETED
|
1908
|
777
|
0
|
0
|
0
|
|
Initial Treatment Phase
NOT COMPLETED
|
248
|
96
|
0
|
0
|
0
|
|
Maintenance Treatment Phase
STARTED
|
0
|
0
|
908
|
897
|
880
|
|
Maintenance Treatment Phase
COMPLETED
|
0
|
0
|
747
|
764
|
701
|
|
Maintenance Treatment Phase
NOT COMPLETED
|
0
|
0
|
161
|
133
|
179
|
Reasons for withdrawal
| Measure |
Esomeprazole 20 mg Once Daily (Initial Phase)
|
Esomeprazole 40 mg Once Daily (Initial Phase)
|
Esomeprazole 20 mg Once Daily (Maintenance Phase)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Maintenance Treatment Phase
Didn'r receive the treatment
|
0
|
0
|
22
|
17
|
29
|
|
Maintenance Treatment Phase
Lost to Follow-up
|
0
|
0
|
8
|
14
|
10
|
|
Maintenance Treatment Phase
Adverse Event
|
0
|
0
|
3
|
2
|
13
|
|
Maintenance Treatment Phase
Protocol specific criteria's development
|
0
|
0
|
1
|
0
|
6
|
|
Maintenance Treatment Phase
Patient's wish
|
0
|
0
|
19
|
9
|
20
|
|
Maintenance Treatment Phase
Protocol Violation
|
0
|
0
|
103
|
88
|
87
|
|
Maintenance Treatment Phase
Ineffectiveness
|
0
|
0
|
5
|
3
|
14
|
Baseline Characteristics
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
Baseline characteristics by cohort
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
n=871 Participants
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=857 Participants
|
Antacid Treatment (Maintenance Phase)
n=830 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Total
n=2558 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
41.5 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
41.79 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 10 • n=5 Participants
|
41.64 years
STANDARD_DEVIATION 9.91 • n=4 Participants
|
|
Sex: Female, Male
Female
|
449 Participants
n=5 Participants
|
415 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
1275 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
422 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
419 Participants
n=5 Participants
|
1283 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPercentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
Outcome measures
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
n=871 Participants
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=857 Participants
|
Antacid Treatment (Maintenance Phase)
n=830 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Efficacy of Three Strategies of Long-term Treatment
|
10.6 Percentage of participants with failure
|
7.8 Percentage of participants with failure
|
43 Percentage of participants with failure
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksTotal percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item.
Outcome measures
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
n=1909 Participants
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=778 Participants
|
Antacid Treatment (Maintenance Phase)
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).
|
3.7 Percentage of participants
|
2.3 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Outcome measure not possible to describe as only 2 patients took Aspirin.
No possibility to describe as only 2 patients took ASA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 to 16 weeksPopulation: 871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)
Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)
Outcome measures
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
n=871 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=801 Participants
|
Antacid Treatment (Maintenance Phase)
n=833 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)
|
—
|
—
|
0.12 Scores on scale
Standard Deviation 0.79
|
0.04 Scores on scale
Standard Deviation 0.73
|
-0.22 Scores on scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 16 weeksFailure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ \[8-10\] : possible anxiety-depression/ \>10 : anxiety-depression)
Outcome measures
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
n=871 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=857 Participants
|
Antacid Treatment (Maintenance Phase)
n=830 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment
|
—
|
—
|
9.8 Percent of participants with failure
|
9.3 Percent of participants with failure
|
43.7 Percent of participants with failure
|
SECONDARY outcome
Timeframe: 12 weeks - maintenance treatment phaseNumber of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.
Outcome measures
| Measure |
Esomeprazole 20 mg Once Daily (Maintenance Phase)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
|
Antacid Treatment (Maintenance Phase)
n=886 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=880 Participants
|
Antacid Treatment (Maintenance Phase)
n=851 Participants
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study
|
—
|
—
|
5 Participants
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: The results of exploratory analyses are not available.
May be used to evaluate the severity of symptoms during the initial visit. Not done
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0Population: The results of exploratory analyses are not available.
May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4Population: The results of exploratory analyses are not available.
May be used to define the success of treatment. Not done
Outcome measures
Outcome data not reported
Adverse Events
Esomeprazole 20 mg Once Daily (Initial Phase)
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Esomeprazole 40 mg Once Daily (Initial Phase)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Esomeprazole 20 mg Once Daily (Maintenance Phase)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Esomeprazole 20 mg on Demand (Maintenance Phase)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Antacid Treatment (Maintenance Phase)
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esomeprazole 20 mg Once Daily (Initial Phase)
n=2156 participants at risk
|
Esomeprazole 40 mg Once Daily (Initial Phase)
n=873 participants at risk
|
Esomeprazole 20 mg Once Daily (Maintenance Phase)
n=886 participants at risk
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=880 participants at risk
|
Antacid Treatment (Maintenance Phase)
n=851 participants at risk
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
ACUTE BALTHAZAR E PANCREATITIS
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.11%
1/880
|
0.00%
0/851
|
|
Psychiatric disorders
ANXIO-DEPRESSI VE STATE
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Musculoskeletal and connective tissue disorders
AGGRAVATION OF INTERVERTEBRAL DISC HERNIATION
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Gastrointestinal disorders
EROSIVE ANTRITIS
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRONCHIAL CANCER
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHE SIS AGGRAVATION BY L5 SPONDYLOLYSIS
|
0.00%
0/2156
|
0.00%
0/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.11%
1/880
|
0.00%
0/851
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOPATHY
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOM A OF GASTRIC ANTRUM
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Infections and infestations
DIGESTIVE VIROSIS
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.11%
1/880
|
0.00%
0/851
|
|
Psychiatric disorders
DEPRESSIVE DISEASE
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARCINOMA OF OESOPHAGUS
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
General disorders
PREEXISTING LUNG CARCINOMA AGGRAVATION
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
ADENOMATOUS POLYP
|
0.00%
0/2156
|
0.00%
0/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
Other adverse events
| Measure |
Esomeprazole 20 mg Once Daily (Initial Phase)
n=2156 participants at risk
|
Esomeprazole 40 mg Once Daily (Initial Phase)
n=873 participants at risk
|
Esomeprazole 20 mg Once Daily (Maintenance Phase)
n=886 participants at risk
|
Esomeprazole 20 mg on Demand (Maintenance Phase)
n=880 participants at risk
|
Antacid Treatment (Maintenance Phase)
n=851 participants at risk
antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
|
|---|---|---|---|---|---|
|
Vascular disorders
Dyspepsia
|
0.09%
2/2156
|
0.23%
2/873
|
0.11%
1/886
|
0.11%
1/880
|
0.35%
3/851
|
|
Gastrointestinal disorders
Diarrhea
|
0.14%
3/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Nervous system disorders
Headache
|
0.23%
5/2156
|
0.23%
2/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Constipation
|
0.09%
2/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
General disorders
Chest pain
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
1/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
4/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Nausea
|
0.19%
4/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Gastrointestinal disorders
Dry mouth
|
0.05%
1/2156
|
0.00%
0/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.24%
2/851
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Oesophagitis
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
3/2156
|
0.11%
1/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
General disorders
Asthenia
|
0.00%
0/2156
|
0.23%
2/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
0.00%
0/2156
|
0.11%
1/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
General disorders
Somnolence
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Metabolism and nutrition disorders
Weight decreased
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Dysphagia
|
0.05%
1/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.24%
2/851
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/2156
|
0.00%
0/873
|
0.11%
1/886
|
0.00%
0/880
|
0.00%
0/851
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.11%
1/880
|
0.00%
0/851
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2156
|
0.00%
0/873
|
0.00%
0/886
|
0.00%
0/880
|
0.12%
1/851
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place