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

Erosive Esophagitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452776
• Other study ID #: TAK-438/OCT-001
• Secondary ID: U1111-1123-9677J
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2011
• Last updated: November 2, 2013
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• TAK-438
TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
• TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change from Baseline in Laboratory Values		Baseline and Week 52	Yes
Secondary	Change from Baseline in Electrocardiograms		Baseline and Week 52	Yes
Secondary	Change from Baseline in Vital Signs		Baseline and Week 52	Yes
Secondary	Change from Baseline in Serum Gastrin		Baseline and Week 52	Yes
Secondary	Change from Baseline in Pepsinogen I and II		Baseline and Week 52	Yes
Secondary	Endoscopically confirmed recurrence rate of Erosive Esophagitis		52 Weeks	No