Duodenal UlcerPhase 3NCT01452724
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
A Phase 3 study testing TAK-438 and Lansoprazole in people with Duodenal Ulcer, run by Takeda at 64 sites in Japan.
Trial summary
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Duodenal Ulcer
- 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
- 372 participants
- Where
- 64 sitesJapan
- Study dates
- Oct 2011to Feb 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 have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
- Outpatient (including short inpatient for examination and others)
Who cannot join
- Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
- Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
- Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
- Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
- Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
- Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
Show all 9Show fewer
- Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
Japan64 sites
Study site
Ageo-shi, Saitama
Study site
Ashikaga-shi, Tochigi
Study site
Daito-shi, Osaka
Study site
Fujiidera-shi, Osaka
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Hachioji-shi, Tokyo
Study site
Hirakata-shi, Osaka
Study site
Hitachi-shi, Ibaraki
Study site
Hitacinaka-shi, Ibaraki
Study site
Kagoshima, Kagoshima-ken
Study site
Kamagaya-shi, Chiba
Study site
Kanoya-shi, Kagoshima-ken
Study site
Kawasaki-shi, Kanagawa
Study site
Kisarazu-shi, Chiba
Study site
Kishiwada-shi, Osaka
Study site
Kitakyushu-shi, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kodaira-shi, Tokyo
Study site
Kofu, Yamanashi
Study site
Kokubunji-shi, Tokyo
Study site
Kumagaya-shi, Saitama
Study site
Kumamoto, Kumamoto
Study site
Kurume-shi, Fukuoka
Study site
Kyoto, Kyoto
Study site
Marugame-shi, Kagawa-ken
Study site
Meguro-ku, Tokyo
Study site
Minato-ku, Tokyo
Study site
Mitaka-shi, Tokyo
Study site
Nagasaki, Nagasaki
Study site
Nishinomiya-shi, Hyōgo
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okayama-ken
Study site
Onga-gun, Fukuoka
Study site
Osaka, Osaka
Study site
Ōta-ku, Tokyo
Study site
Otawara-shi, Tochigi
Study site
Ōtsu, Shiga
Study site
Saga, Saga-ken
Study site
Sakai-shi, Osaka
Study site
Sappori-shi, Hokkaido
Study site
Sasebo-shi, Nagasaki
Study site
Setagaya-ku, Tokyo
Study site
Shimajiri-gun, Okinawa
Study site
Shimonoseki-shi, Yamaguchi
Study site
Shimotsuga-gun, Tochigi
Study site
Shimotsuke-shi, Tochigi
Study site
Shinagawa-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Suita-shi, Osaka
Study site
Tagawa-shi, Fukuoka
Study site
Takamatsu, Kagawa-ken
Study site
Takarazuka-shi, Hyōgo
Study site
Takatsuki-shi, Osaka
Study site
Tokorozawa-shi, Saitama
Study site
Tokushima, Tokushima
Study site
Toyonaka-shi, Osaka
Study site
Toyota-shi, Aichi-ken
Study site
Wakayama, Wakayama
Study site
Yamagata, Yamagata
Study site
Yanagawa-shi, Fukuoka
Study site
Yashiro-shi, Kumamoto
Study site
Yokohama, Kanagawa
Study site
Yukuhashi-shi, Fukuoka
About this study
Official title: A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
- Conditions
- Duodenal Ulcer
- Being tested
- TAK-438, Placebo, Lansoprazole
- Keywords
- Drug Therapy
- Medical subject headings
- 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 20 mg, tablets, orally, once daily for up to 6 weeks.
PlaceboDrug
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
LansoprazoleDrug
Also called AG-1749
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
PlaceboDrug
TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TAK-438 20 mg QD | Experimental | Not described Receives: Drug: TAK-438; Drug: Placebo |
| Lansoprazole 30 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.
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
Measured: 6 weeks
Secondary outcomes (3)
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
Measured: 4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Measured: 2 weeks
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 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 Duodenal 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 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
- NCT01452724
- Sponsor's protocol ID
- TAK-438/CCT-102
- Other IDs
- U1111-1123-8648, JapicCTI-111608
- Status last verified
- Aug 2013
- First submitted
- 16 Sep 2011
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.
PubMed 27891632
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 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 on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer
- ClinicalTrials.gov ID
- NCT01452724
- Acronym / sponsor ID
- TAK-438/CCT-102
- Conditions
- Duodenal Ulcer
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 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 determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
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 QD | Experimental | Drug: TAK-438, Drug: Placebo |
| Lansoprazole 30 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 (2 listed)
- Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
- Outpatient (including short inpatient for examination and others)
Key exclusion criteria (9 listed)
- Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
- Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
- Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
- Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
- Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
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 20 mg, tablets, orally, once daily for up to 6 weeks. | Drug | TAK-438 20 mg QD |
| PlaceboLansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks. | Drug | TAK-438 20 mg QD |
| LansoprazoleAlso: AG-1749Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks. | Drug | Lansoprazole 30 mg QD |
| PlaceboTAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks. | Drug | Lansoprazole 30 mg QD |
Primary outcome
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Time frame: 6 weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
3 secondary outcomes
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
Time frame: 4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Time frame: 2 weeks
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
Time frame: Baseline and 6 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 20 Aug 2013.
- Derived from this study: PubMed 27891632Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.
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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
64 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 Duodenal Ulcer, run by Takeda at 64 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 2 inclusion and 9 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 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 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?
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks (time frame: 6 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 NCT01452724, 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 20 Aug 2013.