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

NCT ID: NCT01474369

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 827 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-02-28

Brief 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.

Conditions

Non-erosive Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TAK-438 10 mg QD

Group Type: EXPERIMENTAL

TAK-438

Intervention Type: DRUG

TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.

TAK-438 20 mg QD

Group Type: EXPERIMENTAL

TAK-438

Intervention Type: DRUG

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

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

TAK-438

TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.

Intervention Type: DRUG

TAK-438

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).

2. 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).

3. 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)

4. Outpatients (hospitalization for testing possible)

Exclusion Criteria

1. 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.

2. 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)

3. 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.

4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication

5. Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders

6. 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Manager

Role: STUDY_DIRECTOR

Takeda

Locations

Nagoya, Aichi-ken, Japan

Abiko-shi, Chiba, Japan

Kashiwa-shi, Chiba, Japan

Noda, Chiba, Japan

Yachiyo-shi, Chiba, Japan

Saijo-shi, Ehime, Japan

Fukuoka, Fukuoka, Japan

Itoshima-shi, Fukuoka, Japan

Kasuya-gun, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Kouriyama-shi, Fukushima, Japan

Gifu, Gifu, Japan

Takayama-shi, Gifu, Japan

Annaka-shi, Gunma, Japan

Hiroshima, Hiroshima, Japan

Asahikawa-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Nishinomiya-shi, Hyōgo, Japan

Takarazuka-shi, Hyōgo, Japan

Sagamihara-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Kochi, Kochi, Japan

Suzaki-shi, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Nagasaki, Nagasaki, Japan

Ōita, Oita Prefecture, Japan

Okayama, Okayama-ken, Japan

Osaka, Osaka, Japan

Takatsuki-shi, Osaka, Japan

Saga, Saga-ken, Japan

Kumagaya-shi, Saitama, Japan

Saitama-shi, Saitama, Japan

Tokorozawa-shi, Saitama, Japan

Otawara-shi, Tochigi, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Hachioji-shi, Tokyo, Japan

Kokubunji-shi, Tokyo, Japan

Nakano-ku, Tokyo, Japan

Oota-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Shimonoseki-shi, Yamaguchi, Japan

Kofu, Yamanashi, Japan

Turu-shi, Yamanashi, Japan

Yamagata, Ymagata, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 28119763 (View on PubMed)

Other Identifiers

U1111-1125-1115

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111663

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-438/CCT-201

Identifier Type: -

Identifier Source: org_study_id