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Gastric UlcersPhase 3NCT01456260

Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

A Phase 3 study testing TAK-438 and Lansoprazole in people with Gastric Ulcers and Duodenal Ulcers, run by Takeda at 97 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 evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Ulcers, Duodenal Ulcers
What is being tested?
TAK-438 and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
97 sitesJapan
Study dates
Sep 2011to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

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 who require continuous NSAID therapy during the treatment period with the study drug
  • Participants who have completed the preceding study
  • Outpatient (including inpatient for examinations)

Who cannot join

  • Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
  • Participants who are scheduled to change the type and dosage regimen of NSAID
  • Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
  • Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
  • Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
  • Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  • Participants with a previous or current history of aspirin-induced asthma

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

Japan97 sites

  • Study site

    Adachi-ku, Tokyo

  • Study site

    Ageo-shi, Saitama

  • Study site

    Akashi-shi, Hyōgo

  • Study site

    Akita, Akita

  • Study site

    Asahikawa-shi, Hokkaido

  • Study site

    Beppu-shi, Oita Prefecture

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Fukui-shi, Fukui

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Fukushima, Fukushima

  • Study site

    Fukuyama-shi, Hiroshima

  • Study site

    Funabashi-shi, Chiba

  • Study site

    Hachiouji-shi, Tokyo

  • Study site

    Hakodate-shi, Hokkaido

  • Study site

    Hakusan-shi, Ishikawa-ken

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hatsukaichi-shi, Hiroshima

  • Study site

    Higashihirosima-shi, Hiroshima

  • Study site

    Higashiibaragi-gun, Ibaragi

  • Study site

    Higashiosaka-shi, Osaka

  • Study site

    Hiki-gun, Saitama

  • Study site

    Himeji-shi, Hyōgo

  • Study site

    Ichihara-shi, Chiba

  • Study site

    Ikoma-shi, Nara

  • Study site

    Itami-shi, Hyōgo

  • Study site

    Itoshima-shi, Fukuoka

  • Study site

    Kako-gun, Hyōgo

  • Study site

    Kamakura-shi, Kanagawa

  • Study site

    Kasugai-shi, Aichi-ken

  • Study site

    Kasukabe-shi, Saitama

  • Study site

    Kato-shi, Hyōgo

  • Study site

    Kawasaki-shi, Kanagawa

  • Study site

    Kitakyusyu-shi, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi, Kochi

  • Study site

    Koga-shi, Ibaragi

  • Study site

    Komatsu-shi, Ishikawa-ken

  • Study site

    Koriyama-shi, Fukushima

  • Study site

    Koto-ku, Tokyo

  • Study site

    Kumagaya-shi, Saitama

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kurashiki-shi, Okayama-ken

  • Study site

    Matsumoto-shi, Nagano

  • Study site

    Matsuyama, Ehime

  • Study site

    Mebashi-shi, Gunma

  • Study site

    Meguro-ku, Tokyo

  • Study site

    Minato-ku, Tokyo

  • Study site

    Mito, Ibaragi

  • Study site

    Moriguchi-shi, Osaka

  • Study site

    Munakata-shi, Fukuoka

  • Study site

    Musashimurayama-shi, Tokyo

  • Study site

    Nagano, Nagano

  • Study site

    Nagareyama-shi, Chiba

  • Study site

    Nagasaki, Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nakano-ku, Tokyo

  • Study site

    Nara, Nara

  • Study site

    Naruto-shi, Tokushima

  • Study site

    Nigata-shi, Niigata

  • Study site

    Niihama-shi, Ehime

  • Study site

    Nishinomiya-shi, Hyōgo

  • Study site

    Obihiro-shi, Hokkaido

  • Study site

    Ogi-shi, Saga-ken

  • Study site

    Ōita, Oita Prefecture

  • Study site

    Onga-gun, Fukuoka

  • Study site

    Osaka, Osaka

  • Study site

    Osakasayama-shi, Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Ōtsu, Shiga

  • Study site

    Sagamihara-shi, Kanagawa

  • Study site

    Saijo-shi, Ehime

  • Study site

    Saitama-shi, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sayama-shi, Saitama

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Seto-shi, Aichi-ken

  • Study site

    Shimonoseki-shi, Yamaguchi

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Sumida-ku, Tokyo

  • Study site

    Sunagawa-shi, Hokkaido

  • Study site

    Tagawa-shi, Fukuoka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takasaki-shi, Gunma

  • Study site

    Toda-shi, Saitama

  • Study site

    Tokorozawa-shi, Saitama

  • Study site

    Tomakomai-shi, Hokkaido

  • Study site

    Tonami-shi, Toyama

  • Study site

    Tondabayashi-shi, Osaka

  • Study site

    Toyama, Toyama

  • Study site

    Tsu, Mie-ken

  • Study site

    Ube-shi, Yamaguchi

  • Study site

    Uji-shi, Kyoto

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yonago-shi, Tottori

  • Study site

    Yuhu-shi, Oita Prefecture

  • Study site

    Yukuhashi-shi, Fukuoka

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Being tested
TAK-438, Placebo, Lansoprazole
Keywords
Drug Therapy
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.

  • TAK-438Drug

    TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.

  • PlaceboDrug

    Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.

  • TAK-438Drug

    TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.

  • PlaceboDrug

    Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.

  • LansoprazoleDrug

    Also called AG-1749

    Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.

  • PlaceboDrug

    TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

Study groups in NCT01456260
Study groupRoleWhat they receive
TAK-438 10 mg QDExperimentalNot described
Receives: Drug: TAK-438; Drug: Placebo
TAK-438 20 mg QDExperimentalNot described
Receives: Drug: TAK-438; Drug: Placebo
Lansoprazole 15 mg QDActive comparatorNot described
Receives: Drug: Lansoprazole; Drug: Placebo

What is being measured

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

  1. Incidence of treatment-emergent adverse events

    Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.

    Measured: Up to 80 weeks.

Secondary outcomes (6)

  1. Change from baseline in Laboratory values

    Measured: Up to 80 weeks.

  2. Change from baseline in Electrocardiograms

    Measured: Up to 80 weeks.

  3. Change from baseline in Vital signs

    Measured: Up to 80 weeks.

  4. Change from baseline in Serum gastrin

    Measured: Up to 80 weeks.

  5. Change from baseline in Pepsinogen I and II

    Measured: Up to 80 weeks.

  6. Recurrence rate of gastric or duodenal ulcer

    Measured: Up to 80 weeks.

Timeline

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

  1. First posted20 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Study completionDec 2013

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456260
Sponsor's protocol ID
TAK-438/OCT-301
Other IDs
U1111-1123-8762, JapicCTI-111611
Status last verified
May 2014
First submitted
16 Sep 2011
Last updated
8 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, Ashida K, Sugano K. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018 Jun;67(6):1042-1051. doi: 10.1136/gutjnl-2017-314010. Epub 2017 Oct 7.

    PubMed 28988197

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-438 and Lansoprazole in people with Gastric Ulcers and Duodenal Ulcers, run by Takeda at 97 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 3 inclusion and 7 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of treatment-emergent adverse events (time frame: Up to 80 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 NCT01456260, 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 8 May 2014.

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