Gastric UlcersPhase 3NCT01456247
Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
A Phase 3 study testing TAK-438 and Lansoprazole in people with Gastric Ulcers and Duodenal Ulcers, run by Takeda at 76 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin. 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
- 439 participants
- Where
- 76 sitesJapan
- Study dates
- Mar 2012to Oct 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 low-dose aspirin 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 low-dose aspirin
- 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
76 sites in 1 country.
76 sites in 1 country
Japan76 sites
Study site
Adachi-ku, Tokyo
Study site
Ageo-shi, Saitama
Study site
Akita, Akita
Study site
Asahikawa-shi, Hokkaido
Study site
Atsugi-shi, Kanagawa
Study site
Chikushino-shi, Fukuoka
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Fukuyama-shi, Hiroshima
Study site
Gifu, Gifu
Study site
Hachioji-shi, Tokyo
Study site
Hatsukaichi-shi, Hiroshima
Study site
Hiki-gun, Saitama
Study site
Hiroshima, Hiroshima
Study site
Ibusuki-shi, Kagoshima-ken
Study site
Ichikawa-shi, Chiba
Study site
Ichikikushikino-shi, Kagoshima-ken
Study site
Imabari, Ehime
Study site
Iwakuni-shi, Yamaguchi
Study site
Izumi-shi, Kagoshima-ken
Study site
Kanazawa, Ishikawa-ken
Study site
Kasuya-gun, Fukuoka
Study site
Kawasaki-shi, Kanagawa
Study site
Kisarazu-shi, Chiba
Study site
Kitakyushu-shi, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kochi, Kochi
Study site
Koga-shi, Ibaragi
Study site
Komaki-shi, Aichi-ken
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
Kyoto, Kyoto
Study site
Matsudo-shi, Chiba
Study site
Matsuyama, Ehime
Study site
Meguro-ku, Tokyo
Study site
Minato-ku, Tokyo
Study site
Miyako-gun, Fukuoka
Study site
Nagasaki, Nagasaki
Study site
Nara, Nara
Study site
Niigata, Niigata
Study site
Niihama-shi, Ehime
Study site
Nishinomiya-shi, Hyōgo
Study site
Nomi-shi, Ishikawa-ken
Study site
Obihiro-shi, Hokkaido
Study site
Ōita, Oita Prefecture
Study site
Onga-gun, Fukuoka
Study site
Osaka, Osaka
Study site
Ōtsu, Shiga
Study site
Sagamihara-shi, Kanagawa
Study site
Saitama-shi, Saitama
Study site
Sakai-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Sayama-shi, Saitama
Study site
Sendai, Miyagi
Study site
Seto-shi, Aichi-ken
Study site
Shimonoseki-shi, Yamaguchi
Study site
Shinjuku-ku, Tokyo
Study site
Shiroyama-shi, Ishikawa-ken
Study site
Takamatsu, Kagawa-ken
Study site
Takarazuka-shi, Hyōgo
Study site
Takasaki-shi, Gunma
Study site
Tokorozawa-shi, Saitama
Study site
Tomakomaki-shi, Hokkaido
Study site
Tonami-shi, Toyama
Study site
Tondabayashi-shi, Osaka
Study site
Toyama, Toyama
Study site
Tsu, Mie-ken
Study site
Tsuchiura-shi, Ibaragi
Study site
Uji-shi, Kyoto
Study site
Utsunomiya, Tochigi
Study site
Yanagawa-shi, Fukuoka
Study site
Yokohama, Kanagawa
Study site
Yukuhashi-shi, Fukuoka
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 Low-dose Aspirin
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
- Conditions
- Gastric Ulcers, Duodenal Ulcers
- 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 group | Role | What they receive |
|---|---|---|
| TAK-438 10 mg QD | Experimental | Not described Receives: Drug: TAK-438; Drug: Placebo |
| TAK-438 20 mg QD | Experimental | Not described Receives: Drug: TAK-438; Drug: Placebo |
| AG-1749 15 mg QD | Active comparator | Not described Receives: Drug: Lansoprazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Change from baseline in Laboratory values
Measured: Up to 80 weeks.
Change from baseline in Electrocardiograms
Measured: Up to 80 weeks.
Change from baseline in Vital signs
Measured: Up to 80 weeks.
Change from baseline in Serum gastrin
Measured: Up to 80 weeks.
Change from baseline in Pepsinogen I and II
Measured: Up to 80 weeks.
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.
- First posted20 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric UlcersStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456247
- Sponsor's protocol ID
- TAK-438/OCT-302
- Other IDs
- U1111-1123-9658, JapicCTI-111616
- Status last verified
- May 2014
- First submitted
- 16 Sep 2011
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, Ashida K, Sugano K. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018 Jun;67(6):1033-1041. doi: 10.1136/gutjnl-2017-314852. Epub 2017 Dec 1.
PubMed 29196436
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Low-dose Aspirin
- ClinicalTrials.gov ID
- NCT01456247
- Acronym / sponsor ID
- TAK-438/OCT-302
- Conditions
- Gastric Ulcers, Duodenal Ulcers
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAK-438 10 mg QD | Experimental | Drug: TAK-438, Drug: Placebo |
| TAK-438 20 mg QD | Experimental | Drug: TAK-438, Drug: Placebo |
| AG-1749 15 mg QD | Active comparator | Drug: Lansoprazole, Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
- Participants who have completed the preceding study
- Outpatient (including inpatient for examinations)
Key exclusion criteria (7 listed)
- 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 low-dose aspirin
- 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
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 |
|---|---|---|
| TAK-438TAK-438 10 mg tablets, orally, once daily for 28-80 weeks. | Drug | TAK-438 10 mg QD |
| PlaceboLansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks. | Drug | TAK-438 10 mg QD |
| TAK-438TAK-438 20 mg tablets, orally, once daily for 28-80 weeks. | Drug | TAK-438 20 mg QD |
| PlaceboLansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks. | Drug | TAK-438 20 mg QD |
| LansoprazoleAlso: AG-1749Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks. | Drug | AG-1749 15 mg QD |
| PlaceboTAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks. | Drug | AG-1749 15 mg QD |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Up to 80 weeks.
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.
6 secondary outcomes
Change from baseline in Laboratory values
Time frame: Up to 80 weeks.
Change from baseline in Electrocardiograms
Time frame: Up to 80 weeks.
Change from baseline in Vital signs
Time frame: Up to 80 weeks.
Change from baseline in Serum gastrin
Time frame: Up to 80 weeks.
Change from baseline in Pepsinogen I and II
Time frame: Up to 80 weeks.
Recurrence rate of gastric or duodenal ulcer
Time frame: Up to 80 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 29196436Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, Ashida K, Sugano K. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018 Jun;67(6):1033-1041. doi: 10.1136/gutjnl-2017-314852. Epub 2017 Dec 1.
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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.
Senior Manager study director
Takeda
76 sites in 1 country: see every site and its status.
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 76 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 76 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 NCT01456247, 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.