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Erosive EsophagitisPhase 3NCT01452776

Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

A Phase 3 study testing TAK-438 in people with Erosive Esophagitis, run by Takeda at 32 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
32 sitesJapan
Study dates
Sep 2011to Jul 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 successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.*
  • "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
  • 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 M-1 (initiation of study drug administration). 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 disorder

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

    Sakaide-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

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.

Being tested
TAK-438
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 10 mg, tablets, orally, once daily for up to 52 weeks.

  • TAK-438Drug

    TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

Study groups in NCT01452776
Study groupRoleWhat they receive
TAK-438 10 mg QDExperimentalNot described
Receives: Drug: TAK-438
TAK-438 20 mg QDExperimentalNot described
Receives: Drug: TAK-438

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 52 Weeks

Secondary outcomes (6)

  1. Change from Baseline in Laboratory Values

    Measured: Baseline and Week 52

  2. Change from Baseline in Electrocardiograms

    Measured: Baseline and Week 52

  3. Change from Baseline in Vital Signs

    Measured: Baseline and Week 52

  4. Change from Baseline in Serum Gastrin

    Measured: Baseline and Week 52

  5. Change from Baseline in Pepsinogen I and II

    Measured: Baseline and Week 52

  6. Endoscopically confirmed recurrence rate of Erosive Esophagitis

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

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
Single blind
Who is masked
Participant
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452776
Sponsor's protocol ID
TAK-438/OCT-001
Other IDs
U1111-1123-9677, JapicCTI-111615
Status last verified
Nov 2013
First submitted
16 Sep 2011
Last updated
5 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-438 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 3 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 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 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?

Incidence of Treatment-emergent Adverse Events (time frame: 52 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 NCT01452776.

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.

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