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

A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)

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.

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: TAK-438; Drug: TAK-438

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan
  • Chiba
    • Abiko-shi, Chiba, Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
    • Itoshima-shi, Fukuoka, Japan
    • Kurume-shi, Fukuoka, Japan
    • Onga-gun, Fukuoka, Japan
  • Gifu
    • Gifu-shi, Gifu, Japan
  • Gunma
    • Annaka-shi, Gunma, Japan
  • Hiroshima
    • Aki-gun, Hiroshima, Japan
    • Hiroshima-shi, Hiroshima, Japan
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
  • Hyogo
    • Amagasaki-shi, Hyogo, Japan
    • Kobe-shi, Hyogo, Japan
    • Takarazuka-shi, Hyogo, Japan
  • Kagawa
    • Sakaide-shi, Kagawa, Japan
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan
  • Kochi
    • Kochi-shi, Kochi, Japan
    • Susaki-shi, Kochi, Japan
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan
  • Kyoto
    • Kyoto-shi, Kyoto, Japan
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan
  • Oita
    • Oita-shi, Oita, Japan
  • Okayama
    • Okayama-shi, Okayama, Japan
  • Osaka
    • Fuziidera-shi, Osaka, Japan
  • Shizuoka
    • Shizuoka-shi, Shizuoka, Japan
  • Tochigi
    • Otawara-shi, Tochigi, Japan
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan
    • Chuo-ku, Tokyo, Japan
    • Nakano-ku, Tokyo, Japan
    • Ota-ku, Tokyo, Japan
    • Setagaya-ku, Tokyo, Japan
  • Yamagata
    • Yamagata-shi, Yamagata, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.

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 M-1 (initiation of study drug administration). 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 disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAK-438 10 mg QD	Drug: TAK-438; TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.; Drug: TAK-438; TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.
Experimental: TAK-438 20 mg QD	Drug: TAK-438; TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.; Drug: TAK-438; TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Endoscopically confirmed recurrence rate of Erosive Esophagitis	52 Weeks

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 2, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis
• Other Study ID Numbers: TAK-438/OCT-001; U1111-1123-9677 (Registry Identifier: WHO); JapicCTI-111615 (Registry Identifier: JapicCTI)