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

NCT01459367 | Completed Phase 3

• 3 other identifiers: TAK-438/CCT-003U1111-1125-1054JapicCTI-111662
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 37

Brief Summary

The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.

Conditions

Erosive Esophagitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment

  Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D 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).

  24 Weeks.

Secondary Outcomes (1)

• Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment

  12 Weeks.

Study Arms (3)

TAK-438 10 mg QD

EXPERIMENTAL

Drug: TAK-438

TAK-438 20 mg QD

EXPERIMENTAL

Drug: TAK-438

Lansoprazole 15 mg QD

ACTIVE COMPARATOR

Drug: Lansoprazole

Interventions

TAK-438 DRUG

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

TAK-438 10 mg QD

Lansoprazole DRUG

In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.

Also known as: AG-1749

Lansoprazole 15 mg QD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At Visit H-1 (start of the treatment period), the participants 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 15% or more of the total participants.
• Outpatients (including inpatient for examination)
• Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.

You may not qualify if:

• 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 H-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

Sponsors & Collaborators

• Takeda: lead

Study Sites (37)

Unknown Facility

Kashiwa-shi, Chiba, Japan

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Yachiyo-shi, Chiba, Japan

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Saijo-shi, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kasuya-gun, Fukuoka, Japan

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Koriyama-shi, Fukushima, Japan

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Takayama-shi, Gifu, Japan

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Annaka-shi, Gunma, Japan

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Asahikawa-shi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Itami-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya-shi, Hyōgo, Japan

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Fujisawa-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Nagasaki, Nagasaki, Japan

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Kishiwada-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Suita-shi, Osaka, Japan

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Takatsuki-shi, Osaka, Japan

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Saga, Saga-ken, Japan

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Kumagaya-shi, Saitama, Japan

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Saitama-shi, Saitama, Japan

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Tokorozawa-shi, Saitama, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Hachioji-shi, Tokyo, Japan

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Kokubunji-shi, Tokyo, Japan

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Shibuya-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Shimonoseki-shi, Yamaguchi, Japan

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Tsuru-shi, Yamanashi, Japan

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Senior Manager

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

JP (37)