PreventionPhase 3NCT01069939

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

A Phase 3 study testing Esomeprazole in people with Prevention, run by AstraZeneca at 46 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Prevention
What is being tested?: Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 427 participants
Where: 46 sitesin 3 countries
Study dates: Feb 2010to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of written informed consent before starting the study-related procedures and examinations
Patients who have the history of gastric and/or duodenal ulcer.
A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Who cannot join

Having gastric or duodenal ulcer (except for ulcer scar).
History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Trial locations and contacts

46 sites in 3 countries.

Country

City, postcode or hospital

46 sites in 3 countries

Japan36 sites

Research Site
Amagasaki, Hyōgo
Research Site
Chūō, Tokyo
Research Site
Daitō, Osaka
Research Site
Fukui-shi, Fukui
Research Site
Fukuoka, Fukuoka
Research Site
Fukushima, Fukushima
Research Site
Fukuyama, Hiroshima
Research Site
Hanyū, Saitama
Research Site
Higashi-ibaraki,, Ibaraki
Research Site
Itami, Hyōgo
Research Site
Kawasaki-shi, Kanagawa
Research Site
Kishiwada, Osaka
Research Site
Kitakyushu-Shi, Fukuoka
Research Site
Kobe, Hyōgo
Research Site
Komatsu, Ishikawa-ken
Research Site
Kōriyama, Fukushima
Research Site
Kure, Hiroshima
Research Site
Matsubara, Osaka
Research Site
Minato, Osaka
Research Site
Minato, Tokyo
Research Site
Nihommatsu, Fukushima
Research Site
Nishinomiya, Hyōgo
Research Site
Nomi, Ishikawa-ken
Research Site
Onga-Gun, Fukuoka
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shimonoseki, Yamaguchi
Research Site
Shimotsuke, Tochigi
Research Site
Shinagawa, Tokyo
Research Site
Shinjuku, Tokyo
Research Site
Shizuoka, Shizuoka
Research Site
Uji, Kyoto
Research Site
Yao, Osaka
Research Site
Yokohama, Kanagawa
Research Site
Yotsukaidou, Chiba
Research Site
Yukuhashi, Fukuoka

Other trials in Japan

South Korea5 sites

Research Site
Busan
Research Site
Gangneung, Gangwon-do
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Wŏnju, Gangwon-do

Other trials in South Korea

Taiwan5 sites

Research Site
Kaohsiung City
Research Site
Kweishan Shiang, Taoyuan Hsien
Research Site
Niao-Song-Shiang, Kaohsiung
Research Site
Tainan
Research Site
Taipei

Other trials in Taiwan

About this study

Official title: A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use

Conditions: Prevention
Being tested: Esomeprazole, Placebo
Keywords: Gastric ulcer, Duodenal ulcer, Low-dose aspirin
Medical subject headings: Stomach Ulcer, Duodenal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsomeprazoleDrug
20mg, capsule, 72 weeks
PlaceboDrug
Placebo, capsule, 72 weeks

Study groups in NCT01069939
Study group	Role	What they receive
Esomeprazole 20mg	Experimental	Esomeprazole 20mg once daily oral Receives: Drug: Esomeprazole
Placebo	Placebo comparator	Placebo once daily oral Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.
Measured: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)

Secondary outcomes (9)

Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.
Measured: Up to 48 weeks (Baseline to last measurement)
Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.
Measured: 12, 24, 36 and 48 weeks
Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened".
Measured: Up to 48 weeks (Baseline to last measurement)
Number of Participants With Adverse Events
Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.
Measured: Up to 70 weeks at the longest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Nov 2011

First posted17 Feb 2010 (estimated)
Study startFeb 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PreventionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 427 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01069939
Sponsor's protocol ID: D961PC00001
Status last verified: Oct 2012
First submitted: 16 Feb 2010
Last updated: 22 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.
PubMed 24326741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity

All Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use
ClinicalTrials.gov ID: NCT01069939
Acronym / sponsor ID: D961PC00001
Conditions: Prevention
Keywords: Gastric ulcer, Duodenal ulcer, Low-dose aspirin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 427 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 17 Feb 2010 (estimated)
Results: Posted 22 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Esomeprazole 20mg	Experimental	Drug: EsomeprazoleEsomeprazole 20mg once daily oral
Placebo	Placebo comparator	Drug: PlaceboPlacebo once daily oral

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of written informed consent before starting the study-related procedures and examinations
Patients who have the history of gastric and/or duodenal ulcer.
A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Key exclusion criteria (2 listed)

Having gastric or duodenal ulcer (except for ulcer scar).
History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Esomeprazole20mg, capsule, 72 weeks	Drug	Esomeprazole 20mg
PlaceboPlacebo, capsule, 72 weeks	Drug	Placebo

Primary outcome

Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
Time frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.

9 secondary outcomes

Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
Time frame: Up to 48 weeks (Baseline to last measurement)
Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
Time frame: 12, 24, 36 and 48 weeks
Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
Time frame: Up to 48 weeks (Baseline to last measurement)
Number of Participants With Adverse Events
Time frame: Up to 70 weeks at the longest

Results and safety

Results posted to the registry on 22 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole 20mg	213	164
Placebo	214	137

Primary outcome: Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.

Time frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis). Number. Unit: Participants

Measure	Esomeprazole 20mg n = 182	Placebo n = 182
0 - 12 weeks	1	16
13 - 24 weeks	1	4
25 - 36 weeks	0	2
37 - 48 weeks	0	0

Esomeprazole 20mg vs Placebo: Hazard Ratio (HR): 0.09 (96.65% CI 0.02 to 0.41), p <0.001, Log Rank

Population analysed: Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole 20mg	17 of 214 (7.9%)	70 of 214 (32.7%)	Not reported
Placebo	15 of 213 (7%)	53 of 213 (24.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24326741Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.

Related trials for Prevention

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kentaro Sugano, MD, PhD principal investigator

Jichi Medical University

46 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole in people with Prevention, run by AstraZeneca at 46 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. (time frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01069939, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.