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Non-erosive Gastroesophageal Reflux DiseasePhase 3NCT01474369

Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

A Phase 3 study testing TAK-438 in people with Non-erosive Gastroesophageal Reflux Disease, run by Takeda at 52 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 investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
TAK-438
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
827 participants
Where
52 sitesJapan
Study dates
Dec 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 with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
  • Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).
  • Participants with severity* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)
  • Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)
  • Outpatients (hospitalization for testing possible)

Who cannot join

  • Participants with an esophagus-related complication [Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) 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 ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.
  • Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
  • Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
  • Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

Japan52 sites

  • Study site

    Abiko-shi, Chiba

  • Study site

    Amagasaki-shi, Hyōgo

  • Study site

    Annaka-shi, Gunma

  • Study site

    Asahikawa-shi, Hokkaido

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Gifu, Gifu

  • Study site

    Hachioji-shi, Tokyo

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Itoshima-shi, Fukuoka

  • Study site

    Kashiwa-shi, Chiba

  • Study site

    Kasuya-gun, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi, Kochi

  • Study site

    Kofu, Yamanashi

  • Study site

    Kokubunji-shi, Tokyo

  • Study site

    Kouriyama-shi, Fukushima

  • Study site

    Kumagaya-shi, Saitama

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kyoto, Kyoto

  • Study site

    Nagasaki, Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nakano-ku, Tokyo

  • Study site

    Nishinomiya-shi, Hyōgo

  • Study site

    Noda, Chiba

  • Study site

    Ōita, Oita Prefecture

  • Study site

    Okayama, Okayama-ken

  • Study site

    Onga-gun, Fukuoka

  • Study site

    Oota-ku, Tokyo

  • Study site

    Osaka, Osaka

  • Study site

    Otawara-shi, Tochigi

  • Study site

    Saga, Saga-ken

  • Study site

    Sagamihara-shi, Kanagawa

  • Study site

    Saijo-shi, Ehime

  • Study site

    Saitama-shi, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shibuya-ku, Tokyo

  • Study site

    Shimonoseki-shi, Yamaguchi

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Suzaki-shi, Kochi

  • Study site

    Takarazuka-shi, Hyōgo

  • Study site

    Takatsuki-shi, Osaka

  • Study site

    Takayama-shi, Gifu

  • Study site

    Tokorozawa-shi, Saitama

  • Study site

    Turu-shi, Yamanashi

  • Study site

    Yachiyo-shi, Chiba

  • Study site

    Yamagata, Ymagata

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.

The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.

Being tested
TAK-438, Placebo
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 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.

  • TAK-438Drug

    TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.

  • PlaceboDrug

    TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.

Study groups in NCT01474369
Study groupRoleWhat they receive
TAK-438 10 mg QDExperimentalNot described
Receives: Drug: TAK-438
TAK-438 20 mg QDExperimentalNot described
Receives: Drug: TAK-438
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of symptom-free days of heartburn symptoms

    Heartburn symptoms will be collected by participant diaries.

    Measured: Week 4

  2. Cumulative symptom improvement rate of heartburn symptoms

    Heartburn symptoms will be collected by participant diaries.

    Measured: Week 4

  3. Severity of heartburn symptoms

    Heartburn symptoms will be collected by participant diaries.

    Measured: Week 4

Secondary outcomes (3)

  1. Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2

    Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.

    Measured: Week 4

  2. Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)

    Heartburn symptoms collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate and severity of heartburn symptoms=evaluation parameters. Participants with Non-Erosive Gastroesophageal Reflux Disease divided into Grade N (endoscopically normal) and M (minimal change) by modified Los Angeles Classification System. Grade definitions: Grade N (endoscopically normal), M (minimal change), A (Mucosal break <5 mm) B (Mucosal break ≥5 mm) C (Mucosal break continuous between 2 or more folds and <75% of circumference) and D (Mucosal break ≥75% of circumference).

    Measured: Week 4

  3. Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.)

    Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.

    Measured: Week 4

Timeline

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

  1. First posted18 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
827 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01474369
Sponsor's protocol ID
TAK-438/CCT-201
Other IDs
U1111-1125-1115, JapicCTI-111663
Status last verified
Jul 2013
First submitted
24 Oct 2011
Last updated
3 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Kinoshita Y, Sakurai Y, Shiino M, Kudou K, Nishimura A, Miyagi T, Iwakiri K, Umegaki E, Ashida K. Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Curr Ther Res Clin Exp. 2016 Dec 21;81-82:1-7. doi: 10.1016/j.curtheres.2016.12.001. eCollection 2016.

    PubMed 28119763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-438 in people with Non-erosive Gastroesophageal Reflux Disease, run by Takeda at 52 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 5 inclusion and 6 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 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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. Some participants in this study may receive a placebo. 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?

Percentage of symptom-free days of heartburn symptoms (time frame: Week 4). The study lists 3 primary outcomes in all. 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 NCT01474369, 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 3 Jul 2013.

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