Clinical trial NCT01452776: Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Esophagitis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 305
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change from Baseline in Laboratory Values
timeFrame: Baseline and Week 52
measure: Change from Baseline in Electrocardiograms
timeFrame: Baseline and Week 52
measure: Change from Baseline in Vital Signs
timeFrame: Baseline and Week 52
measure: Change from Baseline in Serum Gastrin
timeFrame: Baseline and Week 52
measure: Change from Baseline in Pepsinogen I and II
timeFrame: Baseline and Week 52
measure: Endoscopically confirmed recurrence rate of Erosive Esophagitis
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Abiko-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Itoshima-shi
country: Japan
state: Fukuoka
city: Kurume-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Gifu-shi
country: Japan
state: Gifu
city: Annaka-shi
country: Japan
state: Gunma
city: Aki-gun
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Takarazuka-shi
country: Japan
state: Hyogo
city: Sakaide-shi
country: Japan
state: Kagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Susaki-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Oita-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Fuziidera-shi
country: Japan
state: Osaka
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Otawara-shi
country: Japan
state: Tochigi
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Yamagata-shi
country: Japan
state: Yamagata
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References: