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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01459367
First received: October 24, 2011
Last updated: August 22, 2013
Last verified: August 2013
  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:

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 ]

Enrollment: 607
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459367

Locations
Japan
Kashiwa-shi, Chiba, Japan
Yachiyo-shi, Chiba, Japan
Saijo-shi, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Kasuya-gun, Fukuoka, Japan
Koriyama-shi, Fukushima, Japan
Takayama-shi, Gifu, Japan
Annaka-shi, Gunma, Japan
Asahikawa-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Itami-shi, Hyogo, Japan
Kobe-shi, Hyogo, Japan
Nishinomiya-shi, Hyogo, Japan
Fujisawa-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kochi-shi, Kochi, Japan
Kumamoto-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Sendai-shi, Miyagi, Japan
Nagasaki-shi, Nagasaki, Japan
Kishiwada-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Saga-shi, Saga, Japan
Kumagaya-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Hachioji-shi, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Shimonoseki-shi, Yamaguchi, Japan
Tsuru-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
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: August 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

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

ClinicalTrials.gov processed this record on September 18, 2014