CompletedPhase 3

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

Japan305 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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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.\*
✓. 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

What they're measuring

Incidence of Treatment-emergent Adverse Events

Timeframe: 52 Weeks

Trial details

NCT IDNCT01452776

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Erosive Esophagitis trials