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

This study is currently recruiting participants.
Verified July 2012 by Takeda Global Research & Development Center, Inc.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01459367
First received: October 24, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Erosive Esophagitis
Drug: TAK-438
Drug: Lansoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE).

Resource links provided by NLM:


Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment [ Time Frame: 24 Weeks. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment [ Time Frame: 12 Weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: May 2013
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD Drug: TAK-438

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.

Experimental: TAK-438 20 mg QD Drug: TAK-438

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 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

Active Comparator: Lansoprazole 15 mg QD Drug: Lansoprazole

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.

Other Name: AG-1749

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Outpatients (including inpatient for examination)
  3. 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.

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 H-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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459367

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

Locations
Japan
Recruiting
Kashiwa-shi, Chiba, Japan
Active, not recruiting
Yachiyo-shi, Chiba, Japan
Recruiting
Saijo-shi, Ehime, Japan
Recruiting
Fukuoka-shi, Fukuoka, Japan
Recruiting
Kasuya-gun, Fukuoka, Japan
Recruiting
Koriyama-shi, Fukushima, Japan
Not yet recruiting
Takayama-shi, Gifu, Japan
Recruiting
Annaka-shi, Gunma, Japan
Recruiting
Asahikawa-shi, Hokkaido, Japan
Recruiting
Sapporo-shi, Hokkaido, Japan
Recruiting
Itami-shi, Hyogo, Japan
Recruiting
Kobe-shi, Hyogo, Japan
Recruiting
Nishinomiya-shi, Hyogo, Japan
Recruiting
Fujisawa-shi, Kanagawa, Japan
Recruiting
Yokohama-shi, Kanagawa, Japan
Recruiting
Kochi-shi, Kochi, Japan
Recruiting
Kumamoto-shi, Kumamoto, Japan
Recruiting
Kyoto-shi, Kyoto, Japan
Recruiting
Sendai-shi, Miyagi, Japan
Recruiting
Nagasaki-shi, Nagasaki, Japan
Recruiting
Kishiwada-shi, Osaka, Japan
Recruiting
Osaka-shi, Osaka, Japan
Recruiting
Suita-shi, Osaka, Japan
Recruiting
Takatsuki-shi, Osaka, Japan
Recruiting
Saga-shi, Saga, Japan
Recruiting
Kumagaya-shi, Saitama, Japan
Recruiting
Saitama-shi, Saitama, Japan
Recruiting
Tokorozawa-shi, Saitama, Japan
Recruiting
Bunkyo-ku, Tokyo, Japan
Recruiting
Chuo-ku, Tokyo, Japan
Recruiting
Hachioji-shi, Tokyo, Japan
Recruiting
Kokubunji-shi, Tokyo, Japan
Recruiting
Shibuya-ku, Tokyo, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Recruiting
Toshima-ku, Tokyo, Japan
Recruiting
Shimonoseki-shi, Yamaguchi, Japan
Active, not recruiting
Tsuru-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
Study Director: Senior Manager Takeda Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01459367     History of Changes
Other Study ID Numbers: TAK-438/CCT-003, U1111-1125-1054, JapicCTI-111662
Study First Received: October 24, 2011
Last Updated: July 25, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda Global Research & Development Center, Inc.:
Drug Therapy

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013