Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

NCT01452776 | Completed Phase 3

• 3 other identifiers: TAK-438/OCT-001U1111-1123-9677JapicCTI-111615
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.

Conditions

Erosive Esophagitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events

  Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.

  52 Weeks

Secondary Outcomes (6)

• Change from Baseline in Laboratory Values

  Baseline and Week 52

• Change from Baseline in Electrocardiograms

  Baseline and Week 52

• Change from Baseline in Vital Signs

  Baseline and Week 52

• Change from Baseline in Serum Gastrin

  Baseline and Week 52

• Change from Baseline in Pepsinogen I and II

  Baseline and Week 52

Study Arms (2)

TAK-438 10 mg QD

EXPERIMENTAL

Drug: TAK-438

TAK-438 20 mg QD

EXPERIMENTAL

Drug: TAK-438

Interventions

TAK-438 DRUG

TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.

TAK-438 10 mg QD

Eligibility Criteria

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

You may qualify if:

• Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.\*
• \* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
• 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 M-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 (32)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

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Abiko-shi, Chiba, Japan

Location

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Fukuoka, Fukuoka, Japan

Location

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Itoshima-shi, Fukuoka, Japan

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Kurume-shi, Fukuoka, Japan

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Onga-gun, Fukuoka, Japan

Location

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Gifu, Gifu, Japan

Location

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Annaka-shi, Gunma, Japan

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Aki-gun, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

Location

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Sapporo, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

Location

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Kobe, Hyōgo, Japan

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Takarazuka-shi, Hyōgo, Japan

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Sakaide-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

Location

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Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Yamagata, Yamagata, Japan

Location

MeSH Terms

Interventions

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

Study Officials

• Senior Manager

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: October 17, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

JP (32)