Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00595517
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Gastric Ulcer
Duodenal Ulcer
Rheumatoid Arthritis
Osteoarthritis
Lumbago
Intervention Drug: Esomeprazole 20 mg
Enrollment 395
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description Esomeprazole 20 mg once daily oral
Period Title: Overall Study
Started 130
Completed 111
Not Completed 19
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             4
Protocol Violation             2
Recurrence of ulcer             5
usage of prohibited treatment             1
No intention to attend regularly             1
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description Esomeprazole 20 mg once daily oral
Overall Number of Baseline Participants 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants
< 65 years 63
65 - 74 years 43
>= 75 years 24
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants
Male 35
Female 95
1.Primary Outcome
Title Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Hide Description [Not Specified]
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: Participants
125
2.Secondary Outcome
Title Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Hide Description [Not Specified]
Time Frame up to 4 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: Participants
130
3.Secondary Outcome
Title Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Hide Description [Not Specified]
Time Frame up to 12 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: participants
127
4.Secondary Outcome
Title Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Hide Description [Not Specified]
Time Frame up to 24 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description:
Esomeprazole 20 mg once daily oral
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: participants
126
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole 20mg
Hide Arm/Group Description Esomeprazole 20 mg once daily oral
All-Cause Mortality
Esomeprazole 20mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole 20mg
Affected / at Risk (%)
Total   14/130 (10.77%) 
Infections and infestations   
Pyelonephritis  1  2/130 (1.54%) 
Erysipelas  1  1/130 (0.77%) 
Influenza  1  1/130 (0.77%) 
Pneumonia  1  1/130 (0.77%) 
Sepsis  1  1/130 (0.77%) 
Campylobacter Intestinal Infection  1  1/130 (0.77%) 
Metabolism and nutrition disorders   
Dehydration  1  1/130 (0.77%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid Arthritis Aggravated  1  3/130 (2.31%) 
Osteoarthritis Deterioration  1  2/130 (1.54%) 
Pain In Extremity  1  1/130 (0.77%) 
Spondylolisthesis  1  1/130 (0.77%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign Salivary Gland Neoplasm  1  1/130 (0.77%) 
Lung Neoplasm Malignant  1  1/130 (0.77%) 
Nervous system disorders   
Cerebral Infarction  1  1/130 (0.77%) 
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 5%
Esomeprazole 20mg
Affected / at Risk (%)
Total   123/130 (94.62%) 
Gastrointestinal disorders   
Abdominal Pain Upper  1  14/130 (10.77%) 
Constipation  1  12/130 (9.23%) 
Diarrhoea  1  11/130 (8.46%) 
Stomach Discomfort  1  10/130 (7.69%) 
Nausea  1  8/130 (6.15%) 
Stomatitis  1  7/130 (5.38%) 
Vomiting  1  7/130 (5.38%) 
Infections and infestations   
Nasopharyngitis  1  38/130 (29.23%) 
Injury, poisoning and procedural complications   
Contusion  1  7/130 (5.38%) 
Metabolism and nutrition disorders   
Anorexia  1  7/130 (5.38%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid Arthritis  1  17/130 (13.08%) 
Osteoarthritis  1  9/130 (6.92%) 
Arthralgia  1  7/130 (5.38%) 
Nervous system disorders   
Headache  1  8/130 (6.15%) 
Vascular disorders   
Hypertension  1  7/130 (5.38%) 
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.
All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00595517     History of Changes
Other Study ID Numbers: D961HC00005
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: August 4, 2010
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012