Gastric UlcerPhase 3NCT01568385
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy
A Phase 3 study testing TAK-438 in people with Gastric Ulcer and Duodenal Ulcer, run by Takeda at 18 sites in Japan.
Trial summary
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy will be investigated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer
- What is being tested?
- TAK-438
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 18 sitesJapan
- Study dates
- Apr 2012to Sep 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
- Adult, Older adult
Who may be able to join
- Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
- Prior to study commencement, participants who are capable of signing and dating the information/consent form.
- Participants with a chronic disease (rheumatoid arthritis, osteoarthritis, etc.) which requires continuous NSAID oral therapy for pain control during treatment period.
- Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
- Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
- Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
- Outpatient participants (inpatients for examinations are acceptable)
- Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose
Who cannot join
- Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
- Participants who have previously received TAK-438 in a clinical study or as a treatment
- Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
- Participants who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
- Participants with a plan to change the type, dosage or administration of NSAID
- Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
Show all 22Show fewer
- Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
- Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
- Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a history or complication of aspirin asthma
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or NSAIDs
- Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
- Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
- Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
- Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
- Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period.
- Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
- Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers [HBs antigen or HCV antibody positive]); however, participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
- Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
- Serum creatinine value: higher than 2 mg/dL
- Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
- Total bilirubin: higher than 2.0 × the upper limit of normal
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Study site
Annaka-shi, Gunma
Study site
Fuchu-shi, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Funabashi-shi, Chiba
Study site
Hakodate-shi, Hokkaido
Study site
Hiroshima, Hiroshima
Study site
Kanazawa, Ishikawa-ken
Study site
Katsushika-ku, Tokyo
Study site
Kitahiroshima-shi, Hokkaido
Study site
Meguro-ku, Tokyo
Study site
Nagasaki, Nagasaki
Study site
Nakano-ku, Tokyo
Study site
Noda, Chiba
Study site
Sanuki-shi, Kagawa-ken
Study site
Sapporo, Hokkaido
Study site
Sasebo-shi, Nagasaki
Study site
Yashiro-shi, Kumamoto
Study site
Yubari-gun, Hokkaido
About this study
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy will be investigated.
- Conditions
- Gastric Ulcer, Duodenal Ulcer
- Being tested
- TAK-438
- Keywords
- Gastric or 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.
TAK-438Drug
| Study group | Role | What they receive |
|---|---|---|
| TAK-438 20 mg QD | Experimental | Not described Receives: Drug: TAK-438 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies 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
- Treatment
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568385
- Sponsor's protocol ID
- TAK-438/OCT-303
- Other IDs
- U1111-1128-5905, JapicCTI-121789
- Status last verified
- Feb 2014
- First submitted
- 29 Mar 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy
- ClinicalTrials.gov ID
- NCT01568385
- Acronym / sponsor ID
- TAK-438/OCT-303
- Conditions
- Gastric Ulcer, Duodenal Ulcer
- Keywords
- Gastric or duodenal ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Apr 2012 (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 study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy will be investigated.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-438 20 mg QD | Experimental | Drug: TAK-438 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
- Prior to study commencement, participants who are capable of signing and dating the information/consent form.
- Participants with a chronic disease (rheumatoid arthritis, osteoarthritis, etc.) which requires continuous NSAID oral therapy for pain control during treatment period.
- Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
- Outpatient participants (inpatients for examinations are acceptable)
Key exclusion criteria (22 listed)
- Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
- Participants who have previously received TAK-438 in a clinical study or as a treatment
- Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
- Participants who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
- Participants with a plan to change the type, dosage or administration of NSAID
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-438 | Drug | TAK-438 20 mg QD |
Primary outcome
Adverse Event
Time frame: 24 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 10 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 in people with Gastric Ulcer and Duodenal Ulcer, run by Takeda at 18 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 8 inclusion and 22 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Adverse Event (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2014.