Erosive EsophagitisPhase 3NCT01452698
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
A Phase 3 study testing TAK-438 and Lansoprazole in people with Erosive Esophagitis, run by Takeda at 32 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 erosive esophagitis of Grade A to D as defined by the LA classification grading system. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Erosive Esophagitis
- 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
- 409 participants
- Where
- 32 sitesJapan
- Study dates
- Start not givento Aug 2012
- 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
- At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
- Outpatient (including inpatient for examination)
Who cannot join
- Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit 1 (start of the observation period). However, participants with gastric or duodenal erosions are allowed to be included.
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Japan32 sites
Study site
Abiko-shi, Chiba
Study site
Aki-gun, Hiroshima
Study site
Amagasaki-shi, Hyōgo
Study site
Annaka-shi, Gunma
Study site
Chiyoda-ku, Tokyo
Study site
Chuo-ku, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Fuziidera-shi, Osaka
Study site
Gifu, Gifu
Study site
Hiroshima, Hiroshima
Study site
Itoshima-shi, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kochi, Kochi
Study site
Kumamoto, Kumamoto
Study site
Kurume-shi, Fukuoka
Study site
Kyoto, Kyoto
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Nakano-ku, Tokyo
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okayama-ken
Study site
Onga-gun, Fukuoka
Study site
Ōta-ku, Tokyo
Study site
Otawara-shi, Tochigi
Study site
Sakade-shi, Kagawa-ken
Study site
Sapporo, Hokkaido
Study site
Setagaya-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Susaki-shi, Kochi
Study site
Takarazuka-shi, Hyōgo
Study site
Yamagata, Yamagata
Study site
Yokohama, Kanagawa
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
- Conditions
- Erosive Esophagitis
- Being tested
- TAK-438, Placebo, Lansoprazole
- Keywords
- Drug Therapy
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 8 weeks.
PlaceboDrug
Also called AG-1749
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
LansoprazoleDrug
Also called AG-1749
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
PlaceboDrug
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TAK-438 20 mg QD | Experimental | Not described Receives: Drug: TAK-438; Drug: Placebo |
| AG-1749 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 Over 8 Weeks of Erosive Esophagitis
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Measured: 8 Weeks
Secondary outcomes (2)
Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis
Measured: 2 Weeks
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Measured: 4 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)
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies 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
- 409 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
- NCT01452698
- Sponsor's protocol ID
- TAK-438/CCT-002
- Other IDs
- U1111-1123-8356, JapicCTI-111607
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT01452698
- Acronym / sponsor ID
- TAK-438/CCT-002
- Conditions
- Erosive Esophagitis
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (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 erosive esophagitis of Grade A to D as defined by the LA classification grading system.
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 |
| AG-1749 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)
- At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
- Outpatient (including inpatient for examination)
Key exclusion criteria (4 listed)
- Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
- Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit 1 (start of the observation period). However, participants with gastric or duodenal erosions are allowed to be included.
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
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 8 weeks. | Drug | TAK-438 20 mg QD |
| PlaceboAlso: AG-1749Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. | Drug | TAK-438 20 mg QD |
| LansoprazoleAlso: AG-1749Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. | Drug | AG-1749 30 mg QD |
| PlaceboTAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks. | Drug | AG-1749 30 mg QD |
Primary outcome
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Time frame: 8 Weeks
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
2 secondary outcomes
Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis
Time frame: 2 Weeks
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Time frame: 4 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 9 Nov 2012.
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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
32 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 Erosive Esophagitis, run by Takeda at 32 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 4 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 Over 8 Weeks of Erosive Esophagitis (time frame: 8 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 9 Nov 2012.