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Completed

NCT Number: NCT01452776

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

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Outpatient (including inpatient for examination)

Exclusion criteria

  • 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.
  • 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)
  • 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.
  • Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder

Treatment and study plan

TAK-438

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2011
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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