H. Pylori InfectionPhase 3NCT01505127
Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
A Phase 3 study testing TAK-438, Lansoprazole and Amoxicillin in people with H. Pylori Infection, run by Takeda at 35 sites in Japan.
Trial summary
The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- TAK-438, Lansoprazole and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 35 sitesJapan
- Study dates
- Jan 2012to Jun 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 must be H. pylori-positive patients at baseline (Visit 1)
- Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).
- However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
- Outpatient (including inpatient for examination)
Who cannot join
- Participants who have received H.pylori eradication treatment
- Participants who have either acute upper gastrointestinal bleeding, gastric ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], duodenal ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).
- However, participants with gastric erosion or duodenal erosion may be included in the study.
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
- Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Show all 10Show fewer
- Participants with hepatic or renal impairment receiving treatment with colchicines
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
- Participants with infectious mononucleosis
- Participants with an organic disease of the brain or spinal cord
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
Study site
Abiko-shi, Chiba
Study site
Adachi-ku, Tokyo
Study site
Chiyoda-ku, Tokyo
Study site
Ebina-shi, Kanagawa
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Hachioji-shi, Tokyo
Study site
Hirakata-shi, Osaka
Study site
Ishikari-shi, Hokkaido
Study site
Kagoshima, Kagoshima-ken
Study site
Kashiwa-shi, Chiba
Study site
Kobe, Hyōgo
Study site
Kokubunji-shi, Tokyo
Study site
Kumagaya-shi, Saitama
Study site
Kyoto, Kyoto
Study site
Marugame-shi, Kagawa-ken
Study site
Nishi-Tokyo-shi, Tokyo
Study site
Nishinomiya-shi, Hyōgo
Study site
Ōita, Oita Prefecture
Study site
Oota-ku, Tokyo
Study site
Osaka, Osaka
Study site
Ōta-ku, Tokyo
Study site
Saga, Saga-ken
Study site
Sakai-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Setagaya-ku, Tokyo
Study site
Shibuya-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Suita-shi, Osaka
Study site
Takamatsu, Kagawa-ken
Study site
Takatsuki-shi, Osaka
Study site
Tokorozawa-shi, Saitama
Study site
Toyonaka-shi, Osaka
Study site
Yatsushiro-shi, Kumamoto
Study site
Yokohama, Kanagawa
About this study
Official title: A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori
The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.
- Conditions
- H. Pylori Infection
- Being tested
- TAK-438, Lansoprazole, Amoxicillin, Clarithromycin
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-438Drug
LansoprazoleDrug
Also called AG-1749
AmoxicillinDrug
ClarithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| TAK-438 20 mg BID | Experimental | TAK-438 20 mg, tablets, orally, twice daily for 1 week
Lansoprazole placebo-matching capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week Receives: Drug: TAK-438; Drug: Amoxicillin; Drug: Clarithromycin |
| Lansoprazole 30 mg BID | Experimental | TAK-438 placebo-matching tablets, orally, twice daily for 1 week
Lansoprazole 30 mg, capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week Receives: Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate 4 weeks after completion of first-line therapy
The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.
Measured: 4-weeks post-dose (first-line therapy)
Secondary outcomes (1)
H. pylori eradication rate 4 weeks after completion of second-line therapy
Measured: 4-weeks post-dose (second-line therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 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 H. Pylori InfectionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 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
- NCT01505127
- Sponsor's protocol ID
- TAK-438/CCT-401
- Other IDs
- U1111-1126-5073, JapicCTI-111722
- Status last verified
- Nov 2013
- First submitted
- 30 Dec 2011
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
PubMed 26935876
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori
- ClinicalTrials.gov ID
- NCT01505127
- Acronym / sponsor ID
- TAK-438/CCT-401
- Conditions
- H. Pylori Infection
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Jan 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 confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-438 20 mg BID | Experimental | Drug: TAK-438, Drug: Amoxicillin, Drug: ClarithromycinTAK-438 20 mg, tablets, orally, twice daily for 1 week Lansoprazole placebo-matching capsules, orally, twice daily for 1 week Amoxicillin 750 mg, capsules, orally, twice daily for 1 week Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week |
| Lansoprazole 30 mg BID | Experimental | Drug: Lansoprazole, Drug: Amoxicillin, Drug: ClarithromycinTAK-438 placebo-matching tablets, orally, twice daily for 1 week Lansoprazole 30 mg, capsules, orally, twice daily for 1 week Amoxicillin 750 mg, capsules, orally, twice daily for 1 week Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be H. pylori-positive patients at baseline (Visit 1)
- Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).
- However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
- Outpatient (including inpatient for examination)
Key exclusion criteria (10 listed)
- Participants who have received H.pylori eradication treatment
- Participants who have either acute upper gastrointestinal bleeding, gastric ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], duodenal ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).
- However, participants with gastric erosion or duodenal erosion may be included in the study.
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
- Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
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 BID |
| LansoprazoleAlso: AG-1749 | Drug | Lansoprazole 30 mg BID |
| Amoxicillin | Drug | Lansoprazole 30 mg BID, TAK-438 20 mg BID |
| Clarithromycin | Drug | Lansoprazole 30 mg BID, TAK-438 20 mg BID |
Primary outcome
H. pylori eradication rate 4 weeks after completion of first-line therapy
Time frame: 4-weeks post-dose (first-line therapy)
The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.
1 secondary outcome
H. pylori eradication rate 4 weeks after completion of second-line therapy
Time frame: 4-weeks post-dose (second-line therapy)
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 5 Nov 2013.
- Derived from this study: PubMed 26935876Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
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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
35 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, Lansoprazole and Amoxicillin in people with H. Pylori Infection, run by Takeda at 35 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 4 inclusion and 10 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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
H. pylori eradication rate 4 weeks after completion of first-line therapy (time frame: 4-weeks post-dose (first-line therapy)). 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 NCT01505127, 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 5 Nov 2013.