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Trial record 33 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

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ClinicalTrials.gov Identifier: NCT00542789
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Gastric Ulcer
Duodenal Ulcer
Rheumatoid Arthritis
Osteoarthritis
Lumbago
Interventions Drug: Esomeprazole
Drug: Placebo
Enrollment 343
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo
Hide Arm/Group Description Esomeprazole 20 mg once daily oral Placebo once daily oral
Period Title: Overall Study
Started 175 [1] 168 [1]
Completed 134 90
Not Completed 41 78
Reason Not Completed
Adverse Event             18             17
Withdrawal by Subject             7             3
Protocol Violation             8             1
Recurrence of Gastric Ulcer             8             57
[1]
Randomised
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo Total
Hide Arm/Group Description Esomeprazole 20 mg once daily oral Placebo once daily oral Total of all reporting groups
Overall Number of Baseline Participants 175 168 343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 168 participants 343 participants
<65 years 78 91 169
Between 65 and 74 years 59 54 113
>=75 years 36 23 59
Missing 2 0 2
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 168 participants 343 participants
Female 108 100 208
Male 65 68 133
Missing 2 0 2
1.Primary Outcome
Title Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Hide Description The absence of gastric and/or duodenal ulcer throughout the treatment period
Time Frame each visit up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Placebo once daily oral
Overall Number of Participants Analyzed 173 168
Measure Type: Number
Unit of Measure: Participants
167 112
2.Secondary Outcome
Title Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Hide Description The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Placebo once daily oral
Overall Number of Participants Analyzed 173 168
Measure Type: Number
Unit of Measure: Participants
172 133
3.Secondary Outcome
Title Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Hide Description The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Placebo once daily oral
Overall Number of Participants Analyzed 173 168
Measure Type: Number
Unit of Measure: Participants
168 119
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Esomeprazole 20 mg Comparater: Placebo
Hide Arm/Group Description Esomeprazole 20 mg once daily oral Placebo once daily oral
All-Cause Mortality
Experimental: Esomeprazole 20 mg Comparater: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: Esomeprazole 20 mg Comparater: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/173 (6.94%)   5/168 (2.98%) 
Blood and lymphatic system disorders     
Haemorrhagic Anaemia  1  0/173 (0.00%)  1/168 (0.60%) 
Gastrointestinal disorders     
Colonic Polyp  1  1/173 (0.58%)  0/168 (0.00%) 
Enterocolitis  1  1/173 (0.58%)  0/168 (0.00%) 
Vomiting  1  1/173 (0.58%)  0/168 (0.00%) 
Faeces Discoloured  1  0/173 (0.00%)  1/168 (0.60%) 
Upper Gastrointestinal Haemorrhage  1  0/173 (0.00%)  1/168 (0.60%) 
Gastroduodenal Haemorrhage  1  0/173 (0.00%)  1/168 (0.60%) 
Infections and infestations     
Cellulitis  1  1/173 (0.58%)  0/168 (0.00%) 
Pneumonia Pneumococcal  1  1/173 (0.58%)  0/168 (0.00%) 
Pyelonephritis  1  1/173 (0.58%)  0/168 (0.00%) 
Pneumonia Bacterial  1  0/173 (0.00%)  1/168 (0.60%) 
Injury, poisoning and procedural complications     
Medical Device Complication  1  1/173 (0.58%)  0/168 (0.00%) 
Musculoskeletal and connective tissue disorders     
Lumbar Spinal Stenosis  1  1/173 (0.58%)  0/168 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric Cancer  1  1/173 (0.58%)  1/168 (0.60%) 
Small Intestine Carcinoma  1  1/173 (0.58%)  0/168 (0.00%) 
Oesophageal Carcinoma  1  0/173 (0.00%)  1/168 (0.60%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/173 (0.58%)  0/168 (0.00%) 
Vascular disorders     
Shock  1  1/173 (0.58%)  0/168 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Experimental: Esomeprazole 20 mg Comparater: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   134/173 (77.46%)   124/168 (73.81%) 
Gastrointestinal disorders     
Abdominal Pain Upper  1  18/173 (10.40%)  22/168 (13.10%) 
Abdominal Distension  1  15/173 (8.67%)  11/168 (6.55%) 
Stomach Discomfort  1  15/173 (8.67%)  17/168 (10.12%) 
Nausea  1  11/173 (6.36%)  9/168 (5.36%) 
Reflux Oesophagitis  1  10/173 (5.78%)  13/168 (7.74%) 
Diarrhoea  1  9/173 (5.20%)  6/168 (3.57%) 
Constipation  1  7/173 (4.05%)  5/168 (2.98%) 
Dyspepsia  1  7/173 (4.05%)  10/168 (5.95%) 
Hepatobiliary disorders     
Hepatic Function Abnorma  1  6/173 (3.47%)  1/168 (0.60%) 
Infections and infestations     
Nasopharyngitis  1  27/173 (15.61%)  27/168 (16.07%) 
Pharyngitis  1  3/173 (1.73%)  5/168 (2.98%) 
Metabolism and nutrition disorders     
Anorexia  1  11/173 (6.36%)  6/168 (3.57%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  7/173 (4.05%)  3/168 (1.79%) 
Rheumatoid Arthritis  1  7/173 (4.05%)  1/168 (0.60%) 
Vascular disorders     
Hypertension  1  6/173 (3.47%)  5/168 (2.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
ClinicalTrials.gov Identifier: NCT00542789     History of Changes
Other Study ID Numbers: D961HC00001
First Submitted: October 11, 2007
First Posted: October 12, 2007
Results First Submitted: February 16, 2010
Results First Posted: May 28, 2010
Last Update Posted: May 28, 2010