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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00595517
• Collaborator: (none)
• Enrollment: 395
• Locations: 3
• Arm: 1
• Duration (Months): 23
• Patients Per Site: 131.7
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Condition or Disease	Intervention/Treatment	Phase
Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago	Drug: Esomeprazole 20 mg	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 395 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily	Drug: Esomeprazole 20 mg; Esomeprazole 20 mg once daily

Outcome Measures

Primary Outcome Measures

1. Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period [up to 52 weeks]

Secondary Outcome Measures

1. Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [up to 4 weeks after treatment]

2. Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [up to 12 weeks after treatment]

3. Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment [up to 24 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Medical history of gastric and/or duodenal ulcer

• A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

• Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification

• History of esophageal, gastric or duodenal surgery

• Having severe liver disease or chronic renal disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Oita		Japan
2	Research Site	Saitama		Japan
3	Research Site	Tokyo		Japan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Naotsugu Oyama, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00595517
• Other Study ID Numbers: D961HC00005
• First Posted: Jan 16, 2008
• Last Update Posted: Sep 14, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by AstraZeneca: gastrointestinal; GI; NSAID; Japan; Japanese; Gastric ulcer; duodenal ulcer
• Additional relevant MeSH terms: Stomach Ulcer; Duodenal Ulcer; Ulcer; Esomeprazole

Study Results

Participant Flow

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 Detail	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
Arm/Group Description	Esomeprazole 20 mg once daily oral
Period Title: Overall Study
STARTED	130
COMPLETED	111
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
Overall Participants	130
Age, Customized (Number) [Number]
< 65 years	63 48.5%
65 - 74 years	43 33.1%
>= 75 years	24 18.5%
Sex/Gender, Customized (Number) [Number]
Male	35 26.9%
Female	95 73.1%

Outcome Measures

1. Secondary Outcome

Title	Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time Frame	up to 4 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
Measure Participants	130
Number [Participants]	130 100%

2. Secondary Outcome

Title	Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time Frame	up to 12 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
Measure Participants	130
Number [participants]	127 97.7%

3. Secondary Outcome

Title	Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Time Frame	up to 24 weeks after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
Measure Participants	130
Number [participants]	126 96.9%

4. Primary Outcome

Title	Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time Frame	up to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
Measure Participants	130
Number [Participants]	125 96.2%

Adverse Events

Arm/Group Title	Esomeprazole 20mg
Arm/Group Description	Esomeprazole 20 mg once daily oral
All Cause Mortality
	Esomeprazole 20mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Esomeprazole 20mg
	Affected / at Risk (%)	# Events
Total	14/130 (10.8%)
Infections and infestations
Pyelonephritis	2/130 (1.5%)
Erysipelas	1/130 (0.8%)
Influenza	1/130 (0.8%)
Pneumonia	1/130 (0.8%)
Sepsis	1/130 (0.8%)
Campylobacter Intestinal Infection	1/130 (0.8%)
Metabolism and nutrition disorders
Dehydration	1/130 (0.8%)
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis Aggravated	3/130 (2.3%)
Osteoarthritis Deterioration	2/130 (1.5%)
Pain In Extremity	1/130 (0.8%)
Spondylolisthesis	1/130 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm	1/130 (0.8%)
Lung Neoplasm Malignant	1/130 (0.8%)
Nervous system disorders
Cerebral Infarction	1/130 (0.8%)
Other (Not Including Serious) Adverse Events
	Esomeprazole 20mg
	Affected / at Risk (%)	# Events
Total	123/130 (94.6%)
Gastrointestinal disorders
Abdominal Pain Upper	14/130 (10.8%)
Constipation	12/130 (9.2%)
Diarrhoea	11/130 (8.5%)
Stomach Discomfort	10/130 (7.7%)
Nausea	8/130 (6.2%)
Stomatitis	7/130 (5.4%)
Vomiting	7/130 (5.4%)
Infections and infestations
Nasopharyngitis	38/130 (29.2%)
Injury, poisoning and procedural complications
Contusion	7/130 (5.4%)
Metabolism and nutrition disorders
Anorexia	7/130 (5.4%)
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis	17/130 (13.1%)
Osteoarthritis	9/130 (6.9%)
Arthralgia	7/130 (5.4%)
Nervous system disorders
Headache	8/130 (6.2%)
Vascular disorders
Hypertension	7/130 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.