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Functional DyspepsiaPhase 2NCT01089543

A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)

A Phase 2 study testing Rabeprazole in people with Functional Dyspepsia, run by Eisai Co., Ltd. at 46 sites in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Functional Dyspepsia
What is being tested?
Rabeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
338 participants
Where
46 sitesJapan
Study dates
Apr 2010to Aug 2011
Phase
Phase 2
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

  • -Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Who cannot join

  • Participants with neuropsychiatric disorder.
  • Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Japan46 sites

  • Study site

    Akita, Akita

  • Study site

    Bunkyo, Tokyo

  • Study site

    Chikushino-shi, Fukuoka

  • Study site

    Fujieda, Shizuoka

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Gifu, Gifu

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hirakata, Osaka

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Izumo, Shimane

  • Study site

    Kagoshima, Kagoshima-ken

  • Study site

    Karatsu, Saga-ken

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi, Kochi

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kusatsu, Shiga

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Mitaka, Tokyo

  • Study site

    Miyazaki, Miyazaki

  • Study site

    Moriguchi, Osaka

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nakagami, Okinawa

  • Study site

    Nakano City, Tokyo

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Ōita, Oita Prefecture

  • Study site

    Osaka, Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Ōtawara, Tochigi

  • Study site

    Saga, Saga-ken

  • Study site

    Saitama, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya City, Tokyo

  • Study site

    Shibuya City, Tokyo

  • Study site

    Shimotsuga, Tochigi

  • Study site

    Shinagawa, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suita, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takatsuki, Osaka

  • Study site

    Tsuchiura, Ibaraki

  • Study site

    Yamagata, Yamagata

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia

The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.

Being tested
Rabeprazole, Placebo
Keywords
dyspepsia, rabeprazole, Japan
Medical subject headings
Dyspepsia

What participants receive

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

  • RabeprazoleDrug

    Also called E3810

    Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.

  • RabeprazoleDrug

    Also called E3810

    Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.

  • RabeprazoleDrug

    Also called E3810

    Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.

  • PlaceboDrug

    Also called E3810

    Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.

Study groups in NCT01089543
Study groupRoleWhat they receive
Rabeprazole 10 mgExperimentalNot described
Receives: Drug: Rabeprazole
Rabeprazole 20 mgExperimentalNot described
Receives: Drug: Rabeprazole
Rabeprazole 40 mgExperimentalNot described
Receives: Drug: Rabeprazole
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Rate of Complete Dyspepsia Symptom Relief

    The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.

    Measured: Up to 8 Weeks (including 7 days prior)

Secondary outcomes (1)

  1. Rate of Satisfactory Symptom Relief

    The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.

    Measured: Up to 8 Weeks (including 7 days prior)

Timeline

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

  1. First posted18 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01089543
Sponsor's protocol ID
E3810-J081-204
Status last verified
Nov 2013
First submitted
17 Mar 2010
Last updated
24 Dec 2013

Publications

  • Iwakiri R, Tominaga K, Furuta K, Inamori M, Furuta T, Masuyama H, Kanke K, Nagahara A, Haruma K, Kinoshita Y, Higuchi K, Takahashi S, Kusano M, Iwakiri K, Kato M, Hongo M, Hiraishi H, Watanabe S, Miwa H, Naito Y, Fujimoto K, Arakawa T. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013 Oct;38(7):729-40. doi: 10.1111/apt.12444. Epub 2013 Aug 20.

    PubMed 23957383

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rabeprazole in people with Functional Dyspepsia, run by Eisai Co., Ltd. at 46 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 1 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 24 Dec 2013. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Nov 2013). 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?

Rate of Complete Dyspepsia Symptom Relief (time frame: Up to 8 Weeks (including 7 days prior)). 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 NCT01089543, 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 24 Dec 2013.

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