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Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

NCT ID: NCT01452698

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erosive Esophagitis

Keywords

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Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAK-438 20 mg QD

Group Type EXPERIMENTAL

TAK-438

Intervention Type DRUG

TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

Placebo

Intervention Type DRUG

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.

AG-1749 30 mg QD

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

Interventions

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TAK-438

TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Lansoprazole

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.

Intervention Type DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

Intervention Type DRUG

Other Intervention Names

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AG-1749 AG-1749

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Outpatient (including inpatient for examination)

Exclusion Criteria

1. 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.
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 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.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senior Manager

Role: STUDY_DIRECTOR

Takeda

Locations

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Nagoya, Aichi-ken, Japan

Site Status

Abiko-shi, Chiba, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Itoshima-shi, Fukuoka, Japan

Site Status

Kurume-shi, Fukuoka, Japan

Site Status

Onga-gun, Fukuoka, Japan

Site Status

Gifu, Gifu, Japan

Site Status

Annaka-shi, Gunma, Japan

Site Status

Aki-gun, Hiroshima, Japan

Site Status

Hiroshima, Hiroshima, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Amagasaki-shi, Hyōgo, Japan

Site Status

Kobe, Hyōgo, Japan

Site Status

Takarazuka-shi, Hyōgo, Japan

Site Status

Sakade-shi, Kagawa-ken, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Kochi, Kochi, Japan

Site Status

Susaki-shi, Kochi, Japan

Site Status

Kumamoto, Kumamoto, Japan

Site Status

Kyoto, Kyoto, Japan

Site Status

Nagasaki, Nagasaki, Japan

Site Status

Ōita, Oita Prefecture, Japan

Site Status

Okayama, Okayama-ken, Japan

Site Status

Fuziidera-shi, Osaka, Japan

Site Status

Shizuoka, Shizuoka, Japan

Site Status

Otawara-shi, Tochigi, Japan

Site Status

Chiyoda-ku, Tokyo, Japan

Site Status

Chuo-ku, Tokyo, Japan

Site Status

Nakano-ku, Tokyo, Japan

Site Status

Ōta-ku, Tokyo, Japan

Site Status

Setagaya-ku, Tokyo, Japan

Site Status

Yamagata, Yamagata, Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1123-8356

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111607

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-438/CCT-002

Identifier Type: -

Identifier Source: org_study_id