Gastric or Duodenal Ulcers Caused by Low-dose AspirinPhase 2/3NCT01397448

Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

A Phase 2/3 study testing E3810 and Teprenone in people with Gastric or Duodenal Ulcers Caused by Low-dose Aspirin, run by Eisai Co., Ltd. at 49 sites in Japan.

Completed

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

Official record

Search all trials

Trial summary

The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
What is being tested?: E3810 and Teprenone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 472 participants
Where: 49 sitesJapan
Study dates: Jul 2011to Jun 2013
Phase: Phase 2/3
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

Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
Confirmed to have a history of gastric or duodenal ulcer

Who cannot join

-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus

Trial locations and contacts

49 sites in 1 country.

City, postcode or hospital

49 sites in 1 country

Japan49 sites

Study site
Asahikawa, Hokkaido
Study site
Beppu, Oita Prefecture
Study site
Chikuma, Nagano
Study site
Chikushino-shi, Fukuoka
Study site
Daitō, Osaka
Study site
Ebino, Miyazaki
Study site
Fujisawa, Kanagawa
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hamamatsu, Shizuoka
Study site
Hirakata, Osaka
Study site
Hitachi, Ibaraki
Study site
Hitoyoshi, Kumamoto
Study site
Ichikawa, Chiba
Study site
Itami, Hyōgo
Study site
Izumo, Shimane
Study site
Karatsu, Saga-ken
Study site
Kasugai, Aichi-ken
Study site
Kawasaki, Kanagawa
Study site
Kitakyushu, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kochi, Kochi
Study site
Koga, Fukuoka
Study site
Kumamoto, Kumamoto
Study site
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Matsubara, Osaka
Study site
Matsumoto, Nagano
Study site
Mitaka, Tokyo
Study site
Miyazaki, Miyazaki
Study site
Nagano, Nagano
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Ohtawara, Tochigi
Study site
Ōita, Oita Prefecture
Study site
Osaka, Osaka
Study site
Saga, Saga-ken
Study site
Sagamihara, Kanagawa
Study site
Sapporo, Hokkaido
Study site
Setagaya City, Tokyo
Study site
Shinjuku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Suzaka, Nagano
Study site
Takatsuki, Osaka
Study site
Tomakomai, Hokkaido
Study site
Ureshino, Saga-ken
Study site
Yao, Osaka
Study site
Yokohama, Kanagawa
Study site
Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-

Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Being tested: E3810, Teprenone
Keywords: Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
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.

E3810Drug
E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
E3810Drug
E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
TeprenoneDrug
Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.

Study groups in NCT01397448
Study group	Role	What they receive
E3810 5 mg	Experimental	Not described Receives: Drug: E3810
E3810 10 mg	Experimental	Not described Receives: Drug: E3810
Teprenone 150 mg	Active comparator	Not described Receives: Drug: Teprenone

What is being measured

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

Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Measured: 24 weeks

Secondary outcomes (1)

Cumulative Incidence of Bleeding Ulcers
Measured: 24 weeks

Timeline

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

Jul 2011Jun 2013

First posted19 Jul 2011 (estimated)
Study startJul 2011
Primary completionMar 2013
Study completionJun 2013

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.
Other trials for Gastric or Duodenal Ulcers Caused by Low-dose AspirinStudies of the same condition, open and under way.
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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 472 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01397448
Sponsor's protocol ID: E3810-J081-308
Status last verified: Oct 2014
First submitted: 18 Jul 2011
Last updated: 26 Nov 2014
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-
ClinicalTrials.gov ID: NCT01397448
Acronym / sponsor ID: E3810-J081-308
Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 472 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Mar 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 19 Jul 2011 (estimated)
Results: Posted 23 Oct 2014

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: 3

Arm	Type	Receives
E3810 5 mg	Experimental	Drug: E3810
E3810 10 mg	Experimental	Drug: E3810
Teprenone 150 mg	Active comparator	Drug: Teprenone

Who may qualify

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

Key inclusion criteria (2 listed)

Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
Confirmed to have a history of gastric or duodenal ulcer

Key exclusion criteria (1 listed)

-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus

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
E3810E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.	Drug	E3810 5 mg
E3810E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.	Drug	E3810 10 mg
TeprenoneTeprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.	Drug	Teprenone 150 mg

Primary outcome

Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Time frame: 24 weeks
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.

1 secondary outcome

Cumulative Incidence of Bleeding Ulcers
Time frame: 24 weeks

Results and safety

Results posted to the registry on 23 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rabeprazole 5 mg	156	138
Rabeprazole 10 mg	157	142
Teprenone 150 mg	158	140

Primary outcome: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers

Time frame: 24 weeks. Number (95% Confidence Interval). Unit: Events/100 participants/24 weeks

Measure	Rabeprazole 5 mg n = 150	Rabeprazole 10 mg n = 151	Teprenone 150 mg n = 151
Value	2.8 (1.04 to 7.17)	1.4 (0.35 to 5.51)	21.7 (15.84 to 29.27)

Rabeprazole 5 mg vs Teprenone 150 mg: Hazard Ratio (HR): 0.11 (95% CI 0.04 to 0.31), p <0.001, Log Rank
Rabeprazole 10 mg vs Teprenone 150 mg: Hazard Ratio (HR): 0.05 (95% CI 0.01 to 0.23), p <0.001, Log Rank

Population analysed: Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rabeprazole 5 mg	10 of 156 (6.4%)	48 of 156 (30.8%)	Not reported
Rabeprazole 10 mg	6 of 157 (3.8%)	46 of 157 (29.3%)	Not reported
Teprenone 150 mg	10 of 158 (6.3%)	41 of 158 (25.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Nobuyuki Sugisaki study director

Japan/Asia Clinical Research Product Creation Unit

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing E3810 and Teprenone in people with Gastric or Duodenal Ulcers Caused by Low-dose Aspirin, run by Eisai Co., Ltd. at 49 sites in Japan.

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 2 inclusion and 1 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 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 2014). 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?

Cumulative Recurrent Rates of Gastric or Duodenal Ulcers (time frame: 24 weeks). 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 NCT01397448.

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 26 Nov 2014.