Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT01452711

Collaborator

(none)

482

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.

Condition or Disease	Intervention/Treatment	Phase
Gastric Ulcer	Drug: TAK-438 Drug: Placebo Drug: Lansoprazole Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

482 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Gastric Ulcer.

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.
Active Comparator: Lansoprazole 30 mg QD	Drug: Lansoprazole Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Other Names: AG-1749 Drug: Placebo TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

Arm

Intervention/Treatment

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.

Active Comparator: Lansoprazole 30 mg QD

Drug: Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Other Names:

AG-1749

Drug: Placebo

TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

Outcome Measures

Primary Outcome Measures

Endoscopic Healing Rate of Gastric Ulcer Over 8 weeks [8 weeks]
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.

Secondary Outcome Measures

Endoscopic healing Rates of Gastric Ulcer on Endoscopy over 4 weeks [4 weeks]
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2 [2 weeks]
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Gastric Ulcer [Baseline and 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must have endoscopically confirmed gastric ulcers (mucosal defect with white coating) At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1)
Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
Participants with an Acute Gastric Mucosal Lesion (AGML) on endoscopy at baseline (Visit 1)
Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit

Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
Participants with a duodenal ulcer on endoscopy at baseline (Visit 1)
Participants with an ulcer for which medical treatment is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Contacts and Locations

Locations

	City	State	Country
1	Toyota-shi	Aichi	Japan
2	Kamagaya-shi	Chiba	Japan
3	Kisarazu-shi	Chiba	Japan
4	Fukui-shi	Fukui	Japan
5	Fukuoka-shi	Fukuoka	Japan
6	Kitakyushu-shi	Fukuoka	Japan
7	Kurume-shi	Fukuoka	Japan
8	Onga-gun	Fukuoka	Japan
9	Tagawa-shi	Fukuoka	Japan
10	Yanagawa-shi	Fukuoka	Japan
11	Yukuhashi-shi	Fukuoka	Japan
12	Sappori-shi	Hokkaido	Japan
13	Kobe-shi	Hyogo	Japan
14	Nishinomiya-shi	Hyogo	Japan
15	Takarazuka-shi	Hyogo	Japan
16	Hitachi-shi	Ibaraki	Japan
17	Hitacinaka-shi	Ibaraki	Japan
18	Marugame-shi	Kagawa	Japan
19	Takamatsu-shi	Kagawa	Japan
20	Kagoshima-shi	Kagoshima	Japan
21	Kanoya-shi	Kagoshima	Japan
22	Kawasaki-shi	Kanagawa	Japan
23	Yokohama-shi	Kanagawa	Japan
24	Kumamoto-shi	Kumamoto	Japan
25	Yashiro-shi	Kumamoto	Japan
26	Kyoto-shi	Kyoto	Japan
27	Nagasaki-shi	Nagasaki	Japan
28	Sasebo-shi	Nagasaki	Japan
29	Oita-shi	Oita	Japan
30	Okayama-shi	Okayama	Japan
31	Shimajiri-gun	Okinawa	Japan
32	Daito-shi	Osaka	Japan
33	Fujiidera-shi	Osaka	Japan
34	Hirakata-shi	Osaka	Japan
35	Kishiwada-shi	Osaka	Japan
36	Osaka-shi	Osaka	Japan
37	Sakai-shi	Osaka	Japan
38	Suita-shi	Osaka	Japan
39	Takatsuki-shi	Osaka	Japan
40	Toyonaka-shi	Osaka	Japan
41	Saga-shi	Saga	Japan
42	Ageo-shi	Saitama	Japan
43	Kumagaya-shi	Saitama	Japan
44	Tokorozawa-shi	Saitama	Japan
45	Otsu-shi	Shiga	Japan
46	Shizuoka-shi	Shizuoka	Japan
47	Ashikaga-shi	Tochigi	Japan
48	Otawara-shi	Tochigi	Japan
49	Shimotsuga-gun	Tochigi	Japan
50	Shimotsuke-shi	Tochigi	Japan
51	Tokushima-shi	Tokushima	Japan
52	Hachioji-shi	Tokyo	Japan
53	Kodaira-shi	Tokyo	Japan
54	Kokubunji-shi	Tokyo	Japan
55	Meguro-ku	Tokyo	Japan
56	Minato-ku	Tokyo	Japan
57	Mitaka-shi	Tokyo	Japan
58	Ota-ku	Tokyo	Japan
59	Setagaya-ku	Tokyo	Japan
60	Shinagawa-ku	Tokyo	Japan
61	Wakayama-shi	Wakayama	Japan
62	Yamagata-shi	Yamagata	Japan
63	Shimonoseki-shi	Yamaguchi	Japan
64	Kofu-shi	Yamanashi	Japan