Trial Outcomes & Findings for Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer (NCT NCT00595517)
NCT ID: NCT00595517
Last Updated: 2012-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
395 participants
Primary outcome timeframe
up to 52 weeks
Results posted on
2012-09-14
Participant Flow
First participant enrolled 2 Oct 07. Last completed 8 Sept 09. 395 enrolled, 130 registered in study. All registered were included in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy, safety analysis set for summaries of safety variables.
Out of 395 enrolled participants, 130 participants were registered and 265 participants were not registered. The major reasons of no registration were 'Incorrect enrollment' (247 participants) and 'Voluntary discontinuation by participant' (18 participants).
Participant milestones
| Measure |
Esomeprazole 20mg
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Esomeprazole 20mg
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Recurrence of ulcer
|
5
|
|
Overall Study
usage of prohibited treatment
|
1
|
|
Overall Study
No intention to attend regularly
|
1
|
Baseline Characteristics
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Baseline characteristics by cohort
| Measure |
Esomeprazole 20mg
n=130 Participants
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Age, Customized
< 65 years
|
63 Participants
n=5 Participants
|
|
Age, Customized
65 - 74 years
|
43 Participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 52 weeksOutcome measures
| Measure |
Esomeprazole 20mg
n=130 Participants
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
|
125 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks after treatmentOutcome measures
| Measure |
Esomeprazole 20mg
n=130 Participants
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
|
130 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeks after treatmentOutcome measures
| Measure |
Esomeprazole 20mg
n=130 Participants
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
|
127 participants
|
SECONDARY outcome
Timeframe: up to 24 weeks after treatmentOutcome measures
| Measure |
Esomeprazole 20mg
n=130 Participants
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
|
126 participants
|
Adverse Events
Esomeprazole 20mg
Serious events: 14 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esomeprazole 20mg
n=130 participants at risk
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis Aggravated
|
2.3%
3/130
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis Deterioration
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.77%
1/130
|
|
Infections and infestations
Pyelonephritis
|
1.5%
2/130
|
|
Infections and infestations
Erysipelas
|
0.77%
1/130
|
|
Infections and infestations
Influenza
|
0.77%
1/130
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130
|
|
Infections and infestations
Sepsis
|
0.77%
1/130
|
|
Infections and infestations
Campylobacter Intestinal Infection
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.77%
1/130
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
1/130
|
|
Nervous system disorders
Cerebral Infarction
|
0.77%
1/130
|
Other adverse events
| Measure |
Esomeprazole 20mg
n=130 participants at risk
Esomeprazole 20 mg once daily oral
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
29.2%
38/130
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
10.8%
14/130
|
|
Gastrointestinal disorders
Constipation
|
9.2%
12/130
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
11/130
|
|
Gastrointestinal disorders
Stomach Discomfort
|
7.7%
10/130
|
|
Gastrointestinal disorders
Nausea
|
6.2%
8/130
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
7/130
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
7/130
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
13.1%
17/130
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.9%
9/130
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
7/130
|
|
Injury, poisoning and procedural complications
Contusion
|
5.4%
7/130
|
|
Nervous system disorders
Headache
|
6.2%
8/130
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
7/130
|
|
Vascular disorders
Hypertension
|
5.4%
7/130
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
- Publication restrictions are in place
Restriction type: OTHER