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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01452776
First received: September 16, 2011
Last updated: November 2, 2013
Last verified: November 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Incidence of Treatment-emergent Adverse Events [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in Laboratory Values [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Electrocardiograms [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Vital Signs [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Serum Gastrin [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Pepsinogen I and II [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Endoscopically confirmed recurrence rate of Erosive Esophagitis [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD Drug: TAK-438
TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

  Eligibility

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

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
  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: NCT01452776

Locations
Japan
Nagoya-shi, Aichi, Japan
Abiko-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Gifu-shi, Gifu, Japan
Annaka-shi, Gunma, Japan
Aki-gun, Hiroshima, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Amagasaki-shi, Hyogo, Japan
Kobe-shi, Hyogo, Japan
Takarazuka-shi, Hyogo, Japan
Sakaide-shi, Kagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kochi-shi, Kochi, Japan
Susaki-shi, Kochi, Japan
Kumamoto-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Nagasaki-shi, Nagasaki, Japan
Oita-shi, Oita, Japan
Okayama-shi, Okayama, Japan
Fuziidera-shi, Osaka, Japan
Shizuoka-shi, Shizuoka, Japan
Otawara-shi, Tochigi, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Yamagata-shi, Yamagata, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01452776     History of Changes
Other Study ID Numbers: TAK-438/OCT-001, U1111-1123-9677, JapicCTI-111615
Study First Received: September 16, 2011
Last Updated: November 2, 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

ClinicalTrials.gov processed this record on July 23, 2014