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

NCT01452698 | Completed Phase 3

• 3 other identifiers: TAK-438/CCT-002U1111-1123-8356JapicCTI-111607
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Erosive Esophagitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis

  Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O 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).

  8 Weeks

Secondary Outcomes (2)

• Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis

  2 Weeks

• Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

  4 Weeks

Study Arms (2)

TAK-438 20 mg QD

EXPERIMENTAL

Drug: TAK-438; Drug: Placebo

AG-1749 30 mg QD

ACTIVE COMPARATOR

Drug: Lansoprazole; Drug: Placebo

Interventions

TAK-438 DRUG

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

TAK-438 20 mg QD

Placebo 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.

Also known as: AG-1749

TAK-438 20 mg QD

Lansoprazole 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.

Also known as: AG-1749

AG-1749 30 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 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.
• Outpatient (including inpatient for examination)

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 1 (start of the observation period). 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 disorders

Sponsors & Collaborators

• Takeda: lead

Study Sites (32)

Unknown Facility

Nagoya, Aichi-ken, Japan

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Abiko-shi, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Itoshima-shi, Fukuoka, Japan

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Kurume-shi, Fukuoka, Japan

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Onga-gun, Fukuoka, Japan

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Gifu, Gifu, Japan

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Annaka-shi, Gunma, Japan

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Aki-gun, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Takarazuka-shi, Hyōgo, Japan

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Sakade-shi, Kagawa-ken, Japan

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Yokohama, Kanagawa, Japan

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Kochi, Kochi, Japan

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Susaki-shi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Nagasaki, Nagasaki, Japan

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Ōita, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Fuziidera-shi, Osaka, Japan

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Shizuoka, Shizuoka, Japan

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Otawara-shi, Tochigi, Japan

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Chiyoda-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Nakano-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Yamagata, Yamagata, 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: September 16, 2011
• First Posted: October 17, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

JP (32)