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

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ClinicalTrials.gov Identifier: NCT01452776
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: TAK-438 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : September 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

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.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

Primary Outcome Measures :
  1. Incidence of Treatment-emergent Adverse Events [ Time Frame: 52 Weeks ]
    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 :
  1. Change from Baseline in Laboratory Values [ Time Frame: Baseline and Week 52 ]
  2. Change from Baseline in Electrocardiograms [ Time Frame: Baseline and Week 52 ]
  3. Change from Baseline in Vital Signs [ Time Frame: Baseline and Week 52 ]
  4. Change from Baseline in Serum Gastrin [ Time Frame: Baseline and Week 52 ]
  5. Change from Baseline in Pepsinogen I and II [ Time Frame: Baseline and Week 52 ]
  6. Endoscopically confirmed recurrence rate of Erosive Esophagitis [ Time Frame: 52 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452776

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
Study Director: Senior Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01452776     History of Changes
Other Study ID Numbers: TAK-438/OCT-001
U1111-1123-9677 ( Registry Identifier: WHO )
JapicCTI-111615 ( Registry Identifier: JapicCTI )
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases