Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
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Purpose
The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Erosive Esophagitis |
Drug: TAK-438 Drug: Lansoprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE). |
- Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment [ Time Frame: 24 Weeks. ] [ Designated as safety issue: No ]Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
- Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment [ Time Frame: 12 Weeks. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2013 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TAK-438 10 mg QD |
Drug: TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
| Experimental: TAK-438 20 mg QD |
Drug: TAK-438
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks. |
| Active Comparator: Lansoprazole 15 mg QD |
Drug: Lansoprazole
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks. Other Name: AG-1749
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At Visit H-1 (start of the treatment period), the participants must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 15% or more of the total participants.
- Outpatients (including inpatient for examination)
- Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.
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 H-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
Contacts and Locations| Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
| Japan | |
| Recruiting | |
| Kashiwa-shi, Chiba, Japan | |
| Active, not recruiting | |
| Yachiyo-shi, Chiba, Japan | |
| Recruiting | |
| Saijo-shi, Ehime, Japan | |
| Recruiting | |
| Fukuoka-shi, Fukuoka, Japan | |
| Recruiting | |
| Kasuya-gun, Fukuoka, Japan | |
| Recruiting | |
| Koriyama-shi, Fukushima, Japan | |
| Not yet recruiting | |
| Takayama-shi, Gifu, Japan | |
| Recruiting | |
| Annaka-shi, Gunma, Japan | |
| Recruiting | |
| Asahikawa-shi, Hokkaido, Japan | |
| Recruiting | |
| Sapporo-shi, Hokkaido, Japan | |
| Recruiting | |
| Itami-shi, Hyogo, Japan | |
| Recruiting | |
| Kobe-shi, Hyogo, Japan | |
| Recruiting | |
| Nishinomiya-shi, Hyogo, Japan | |
| Recruiting | |
| Fujisawa-shi, Kanagawa, Japan | |
| Recruiting | |
| Yokohama-shi, Kanagawa, Japan | |
| Recruiting | |
| Kochi-shi, Kochi, Japan | |
| Recruiting | |
| Kumamoto-shi, Kumamoto, Japan | |
| Recruiting | |
| Kyoto-shi, Kyoto, Japan | |
| Recruiting | |
| Sendai-shi, Miyagi, Japan | |
| Recruiting | |
| Nagasaki-shi, Nagasaki, Japan | |
| Recruiting | |
| Kishiwada-shi, Osaka, Japan | |
| Recruiting | |
| Osaka-shi, Osaka, Japan | |
| Recruiting | |
| Suita-shi, Osaka, Japan | |
| Recruiting | |
| Takatsuki-shi, Osaka, Japan | |
| Recruiting | |
| Saga-shi, Saga, Japan | |
| Recruiting | |
| Kumagaya-shi, Saitama, Japan | |
| Recruiting | |
| Saitama-shi, Saitama, Japan | |
| Recruiting | |
| Tokorozawa-shi, Saitama, Japan | |
| Recruiting | |
| Bunkyo-ku, Tokyo, Japan | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan | |
| Recruiting | |
| Hachioji-shi, Tokyo, Japan | |
| Recruiting | |
| Kokubunji-shi, Tokyo, Japan | |
| Recruiting | |
| Shibuya-ku, Tokyo, Japan | |
| Recruiting | |
| Shinjuku-ku, Tokyo, Japan | |
| Recruiting | |
| Toshima-ku, Tokyo, Japan | |
| Recruiting | |
| Shimonoseki-shi, Yamaguchi, Japan | |
| Active, not recruiting | |
| Tsuru-shi, Yamanashi, Japan | |
| Study Director: | Senior Manager | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01459367 History of Changes |
| Other Study ID Numbers: | TAK-438/CCT-003, U1111-1125-1054, JapicCTI-111662 |
| Study First Received: | October 24, 2011 |
| Last Updated: | July 25, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Drug Therapy |
Additional relevant MeSH terms:
|
Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Lansoprazole Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013