Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
This study has been completed.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01452698
First received: September 16, 2011
Last updated: November 7, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
| Condition | Intervention | Phase |
|---|---|---|
|
Erosive Esophagitis |
Drug: TAK-438 Drug: Placebo 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 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O 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).
Secondary Outcome Measures:
- Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
- Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 409 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TAK-438 20 mg QD |
Drug: TAK-438
TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. Other Name: AG-1749
|
| Active Comparator: AG-1749 30 mg QD |
Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks. Other Name: AG-1749
Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At Visit 1 (start of the observation period), the participant 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 30% (120 participants) or more of the total participants.
- 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 1 (start of the observation period). 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 disorders
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452698
Locations
| Japan | |
| Nagoya-shi, Aichi, Japan | |
| Abiko-shi, Chiba, Japan | |
| Fukuoka-shi, Fukuoka, Japan | |
| Itoshima-shi, Fukuoka, Japan | |
| Kurume-shi, Fukuoka, Japan | |
| Onga-gun, Fukuoka, Japan | |
| Gifu-shi, Gifu, Japan | |
| Annaka-shi, Gunma, Japan | |
| Aki-gun, Hiroshima, Japan | |
| Hiroshima-shi, Hiroshima, Japan | |
| Sapporo-shi, Hokkaido, Japan | |
| Amagasaki-shi, Hyogo, Japan | |
| Kobe-shi, Hyogo, Japan | |
| Takarazuka-shi, Hyogo, Japan | |
| Sakade-shi, Kagawa, Japan | |
| Yokohama-shi, Kanagawa, Japan | |
| Kochi-shi, Kochi, Japan | |
| Susaki-shi, Kochi, Japan | |
| Kumamoto-shi, Kumamoto, Japan | |
| Kyoto-shi, Kyoto, Japan | |
| Nagasaki-shi, Nagasaki, Japan | |
| Oita-shi, Oita, Japan | |
| Okayama-shi, Okayama, Japan | |
| Fuziidera-shi, Osaka, Japan | |
| Shizuoka-shi, Shizuoka, Japan | |
| Otawara-shi, Tochigi, Japan | |
| Chiyoda-ku, Tokyo, Japan | |
| Chuo-ku, Tokyo, Japan | |
| Nakano-ku, Tokyo, Japan | |
| Ota-ku, Tokyo, Japan | |
| Setagaya-ku, Tokyo, Japan | |
| Yamagata-shi, Yamagata, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| 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: | NCT01452698 History of Changes |
| Other Study ID Numbers: | TAK-438/CCT-002, U1111-1123-8356, JapicCTI-111607 |
| Study First Received: | September 16, 2011 |
| Last Updated: | November 7, 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