Trial Outcomes & Findings for Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID (NCT NCT00542789)
NCT ID: NCT00542789
Last Updated: 2010-05-28
Results Overview
The absence of gastric and/or duodenal ulcer throughout the treatment period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
343 participants
Primary outcome timeframe
each visit up to 24 weeks
Results posted on
2010-05-28
Participant Flow
343 randomised participants 341 in Full Analysis set and safety analysis set. Full set used for summaries of baseline char. and efficacy variables. Safety set used for summaries of safety variables. 2 excluded, took no investigational drug or had protocol deviation. 173 Esomeprazole 20 and 168 placebo had baseline information and were summarised.
Out of 1246 enrolled participants, 343 participants were randomised and 903 participants were not randomised. The major reasons of no randomisation were 'Did not meet eligibility criteria' (877 participants) and 'Voluntary discontinuation by participant' (24 participants).
Participant milestones
| Measure |
Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
Placebo once daily oral
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
168
|
|
Overall Study
COMPLETED
|
134
|
90
|
|
Overall Study
NOT COMPLETED
|
41
|
78
|
Reasons for withdrawal
| Measure |
Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
Placebo once daily oral
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
17
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Protocol Violation
|
8
|
1
|
|
Overall Study
Recurrence of Gastric Ulcer
|
8
|
57
|
Baseline Characteristics
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Baseline characteristics by cohort
| Measure |
Experimental: Esomeprazole 20 mg
n=175 Participants
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 Participants
Placebo once daily oral
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
78 participants
n=5 Participants
|
91 participants
n=7 Participants
|
169 participants
n=5 Participants
|
|
Age, Customized
Between 65 and 74 years
|
59 participants
n=5 Participants
|
54 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
36 participants
n=5 Participants
|
23 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Age, Customized
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
108 participants
n=5 Participants
|
100 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
65 participants
n=5 Participants
|
68 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: each visit up to 24 weeksPopulation: Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.
The absence of gastric and/or duodenal ulcer throughout the treatment period
Outcome measures
| Measure |
Experimental: Esomeprazole 20 mg
n=173 Participants
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 Participants
Placebo once daily oral
|
|---|---|---|
|
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
|
167 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksThe absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Outcome measures
| Measure |
Experimental: Esomeprazole 20 mg
n=173 Participants
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 Participants
Placebo once daily oral
|
|---|---|---|
|
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
|
172 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksThe absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Outcome measures
| Measure |
Experimental: Esomeprazole 20 mg
n=173 Participants
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 Participants
Placebo once daily oral
|
|---|---|---|
|
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
|
168 Participants
|
119 Participants
|
Adverse Events
Experimental: Esomeprazole 20 mg
Serious events: 12 serious events
Other events: 134 other events
Deaths: 0 deaths
Comparater: Placebo
Serious events: 5 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Esomeprazole 20 mg
n=173 participants at risk
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 participants at risk
Placebo once daily oral
|
|---|---|---|
|
Gastrointestinal disorders
Colonic Polyp
|
0.58%
1/173
|
0.00%
0/168
|
|
Gastrointestinal disorders
Enterocolitis
|
0.58%
1/173
|
0.00%
0/168
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/173
|
0.00%
0/168
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/173
|
0.60%
1/168
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/173
|
0.60%
1/168
|
|
Gastrointestinal disorders
Gastroduodenal Haemorrhage
|
0.00%
0/173
|
0.60%
1/168
|
|
Infections and infestations
Cellulitis
|
0.58%
1/173
|
0.00%
0/168
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.58%
1/173
|
0.00%
0/168
|
|
Infections and infestations
Pyelonephritis
|
0.58%
1/173
|
0.00%
0/168
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/173
|
0.60%
1/168
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.58%
1/173
|
0.60%
1/168
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Carcinoma
|
0.58%
1/173
|
0.00%
0/168
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/173
|
0.60%
1/168
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
0.58%
1/173
|
0.00%
0/168
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.58%
1/173
|
0.00%
0/168
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.58%
1/173
|
0.00%
0/168
|
|
Vascular disorders
Shock
|
0.58%
1/173
|
0.00%
0/168
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/173
|
0.60%
1/168
|
Other adverse events
| Measure |
Experimental: Esomeprazole 20 mg
n=173 participants at risk
Esomeprazole 20 mg once daily oral
|
Comparater: Placebo
n=168 participants at risk
Placebo once daily oral
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.4%
18/173
|
13.1%
22/168
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.7%
15/173
|
6.5%
11/168
|
|
Gastrointestinal disorders
Stomach Discomfort
|
8.7%
15/173
|
10.1%
17/168
|
|
Gastrointestinal disorders
Nausea
|
6.4%
11/173
|
5.4%
9/168
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
5.8%
10/173
|
7.7%
13/168
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
9/173
|
3.6%
6/168
|
|
Gastrointestinal disorders
Constipation
|
4.0%
7/173
|
3.0%
5/168
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
7/173
|
6.0%
10/168
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
27/173
|
16.1%
27/168
|
|
Infections and infestations
Pharyngitis
|
1.7%
3/173
|
3.0%
5/168
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
7/173
|
1.8%
3/168
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
4.0%
7/173
|
0.60%
1/168
|
|
Metabolism and nutrition disorders
Anorexia
|
6.4%
11/173
|
3.6%
6/168
|
|
Hepatobiliary disorders
Hepatic Function Abnorma
|
3.5%
6/173
|
0.60%
1/168
|
|
Vascular disorders
Hypertension
|
3.5%
6/173
|
3.0%
5/168
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER