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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00542789
• Collaborator: (none)
• Enrollment: 343
• Locations: 39
• Arms: 2
• Duration (Months): 18.1
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 343 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
• Study Start Date: Aug 1, 2007
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo	Drug: Placebo; once daily oral
Experimental: 2 Esomeprazole 20 mg	Drug: Esomeprazole; 20mg once daily oral; Other Names: Nexium

Outcome Measures

Primary Outcome Measures

1. Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period [each visit up to 24 weeks]

   The absence of gastric and/or duodenal ulcer throughout the treatment period

Secondary Outcome Measures

1. Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [up to 4 weeks]

   The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment

2. Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [up to 12 weeks]

   The absence of gastric and/or duodenal ulcer up to 12 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	Chiryu	Aichi	Japan
2	Research Site	Seto	Aichi	Japan
3	Research Site	Yotukaido	Chiba	Japan
4	Research Site	Mizumaki	Fukuoka	Japan
5	Research Site	Sapporo	Hokkaido	Japan
6	Research Site	Akashi	HYOGOi	Japan
7	Research Site	Itami	Hyogo	Japan
8	Research Site	Koto	Hyogo	Japan
9	Research Site	Nishinomiya	Hyogo	Japan
10	Research Site	Hitachi	Ibaragi	Japan
11	Research Site	Morioka	Iwate	Japan
12	Research Site	Sagamihara	Kanagawa	Japan
13	Research Site	Yokohama	Kanagawa	Japan
14	Research Site	Nagaokakyo	Kyoto	Japan
15	Research Site	Chiisagata	Nagano	Japan
16	Research Site	Matsumoto	Nagano	Japan
17	Research Site	Sasebo	Nagasaki	Japan
18	Research Site	Beppu	Oita	Japan
19	Research Site	Ihara	Okayama	Japan
20	Research Site	Hirakata	Osaka	Japan
21	Research Site	Sakai	Osaka	Japan
22	Research Site	Suita	Osaka	Japan
23	Research Site	Takatsuki	Osaka	Japan
24	Research Site	Kawagoe	Saitama	Japan
25	Research Site	Fukuroi	Shizuoka	Japan
26	Research Site	Hamamatsu	Shizuoka	Japan
27	Research Site	Izunokuni	Shizuoka	Japan
28	Research Site	Maikinohara	Shizuoka	Japan
29	Research Site	Yaizu	Shizuoka	Japan
30	Research Site	Shimotsuke	Tochigi	Japan
31	Research Site	Chiyoda	Tokyo	Japan
32	Research Site	Koto	Tokyo	Japan
33	Research Site	Musashimurayama	Tokyo	Japan
34	Research Site	Kyoto		Japan
35	Research Site	Nagano		Japan
36	Research Site	Oita		Japan
37	Research Site	Osaka		Japan
38	Research Site	Saitama		Japan
39	Research Site	Shizuoka		Japan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Naotsugu Oyama, AstraZeneca Japan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00542789
• Other Study ID Numbers: D961HC00001
• First Posted: Oct 12, 2007
• Last Update Posted: May 28, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: 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	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 Detail	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
Arm/Group Description	Esomeprazole 20 mg once daily oral	Placebo once daily oral
Period Title: Overall Study
STARTED	175	168
COMPLETED	134	90
NOT COMPLETED	41	78

Baseline Characteristics

Arm/Group Title	Experimental: Esomeprazole 20 mg	Comparater: Placebo	Total
Arm/Group Description	Esomeprazole 20 mg once daily oral	Placebo once daily oral	Total of all reporting groups
Overall Participants	175	168	343
Age, Customized (participants) [Number]
<65 years	78 44.6%	91 54.2%	169 49.3%
Between 65 and 74 years	59 33.7%	54 32.1%	113 32.9%
>=75 years	36 20.6%	23 13.7%	59 17.2%
Missing	2 1.1%	0 0%	2 0.6%
Sex/Gender, Customized (participants) [Number]
Female	108 61.7%	100 59.5%	208 60.6%
Male	65 37.1%	68 40.5%	133 38.8%
Missing	2 1.1%	0 0%	2 0.6%

Outcome Measures

1. Primary Outcome

Title	Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Description	The absence of gastric and/or duodenal ulcer throughout the treatment period
Time Frame	each visit up to 24 weeks

Outcome Measure Data

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
Arm/Group Description	Esomeprazole 20 mg once daily oral	Placebo once daily oral
Measure Participants	173	168
Number [Participants]	167 95.4%	112 66.7%

2. Secondary Outcome

Title	Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Description	The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time Frame	up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Esomeprazole 20 mg	Comparater: Placebo
Arm/Group Description	Esomeprazole 20 mg once daily oral	Placebo once daily oral
Measure Participants	173	168
Number [Participants]	172 98.3%	133 79.2%

3. Secondary Outcome

Title	Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Description	The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Esomeprazole 20 mg	Comparater: Placebo
Arm/Group Description	Esomeprazole 20 mg once daily oral	Placebo once daily oral
Measure Participants	173	168
Number [Participants]	168 96%	119 70.8%

Adverse Events

Arm/Group Title	Experimental: Esomeprazole 20 mg		Comparater: Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Experimental: Esomeprazole 20 mg		Comparater: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/173 (6.9%)		5/168 (3%)
Blood and lymphatic system disorders
Haemorrhagic Anaemia	0/173 (0%)		1/168 (0.6%)
Gastrointestinal disorders
Colonic Polyp	1/173 (0.6%)		0/168 (0%)
Enterocolitis	1/173 (0.6%)		0/168 (0%)
Vomiting	1/173 (0.6%)		0/168 (0%)
Faeces Discoloured	0/173 (0%)		1/168 (0.6%)
Upper Gastrointestinal Haemorrhage	0/173 (0%)		1/168 (0.6%)
Gastroduodenal Haemorrhage	0/173 (0%)		1/168 (0.6%)
Infections and infestations
Cellulitis	1/173 (0.6%)		0/168 (0%)
Pneumonia Pneumococcal	1/173 (0.6%)		0/168 (0%)
Pyelonephritis	1/173 (0.6%)		0/168 (0%)
Pneumonia Bacterial	0/173 (0%)		1/168 (0.6%)
Injury, poisoning and procedural complications
Medical Device Complication	1/173 (0.6%)		0/168 (0%)
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis	1/173 (0.6%)		0/168 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer	1/173 (0.6%)		1/168 (0.6%)
Small Intestine Carcinoma	1/173 (0.6%)		0/168 (0%)
Oesophageal Carcinoma	0/173 (0%)		1/168 (0.6%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/173 (0.6%)		0/168 (0%)
Vascular disorders
Shock	1/173 (0.6%)		0/168 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: Esomeprazole 20 mg		Comparater: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	134/173 (77.5%)		124/168 (73.8%)
Gastrointestinal disorders
Abdominal Pain Upper	18/173 (10.4%)		22/168 (13.1%)
Abdominal Distension	15/173 (8.7%)		11/168 (6.5%)
Stomach Discomfort	15/173 (8.7%)		17/168 (10.1%)
Nausea	11/173 (6.4%)		9/168 (5.4%)
Reflux Oesophagitis	10/173 (5.8%)		13/168 (7.7%)
Diarrhoea	9/173 (5.2%)		6/168 (3.6%)
Constipation	7/173 (4%)		5/168 (3%)
Dyspepsia	7/173 (4%)		10/168 (6%)
Hepatobiliary disorders
Hepatic Function Abnorma	6/173 (3.5%)		1/168 (0.6%)
Infections and infestations
Nasopharyngitis	27/173 (15.6%)		27/168 (16.1%)
Pharyngitis	3/173 (1.7%)		5/168 (3%)
Metabolism and nutrition disorders
Anorexia	11/173 (6.4%)		6/168 (3.6%)
Musculoskeletal and connective tissue disorders
Back Pain	7/173 (4%)		3/168 (1.8%)
Rheumatoid Arthritis	7/173 (4%)		1/168 (0.6%)
Vascular disorders
Hypertension	6/173 (3.5%)		5/168 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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