Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Condition	Intervention	Phase
Gastric Ulcers Duodenal Ulcers	Drug: TAK-438 Drug: Placebo Drug: Lansoprazole	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin

Resource links provided by NLM:

Drug Information available for: Aspirin Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.

Secondary Outcome Measures:

Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Gastric mucosal injury [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Duodenal mucosal injury [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	630
Study Start Date:	September 2011
Estimated Study Completion Date:	June 2013

Arms	Assigned Interventions
Experimental: TAK-438 10 mg QD	Drug: TAK-438 TAK-438 10 mg tablets, orally, once daily for up to 24 weeks. Drug: Placebo Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Experimental: TAK-438 20 mg QD	Drug: TAK-438 TAK-438 20 mg tablets, orally, once daily for up to 24 weeks. Drug: Placebo Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Active Comparator: Lansoprazole 15 mg QD	Drug: Lansoprazole Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks. Other Name: AG-1749 Drug: Placebo TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
Outpatient (including inpatient for examinations)

Exclusion Criteria:

Participants scheduled to change the type and dosage regimen of low-dose aspirin
Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Participants with a previous or current history of aspirin-induced asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452763

Contacts

Contact: Takeda Study Registration Call Center

800-778-2860

medicalinformation@tpna.com

Hide Study Locations

Locations

Japan
	Recruiting
Komaki-shi, Aichi, Japan
	Recruiting
Seto-shi, Aichi, Japan
	Recruiting
Akita-shi, Akita, Japan
	Recruiting
Ichikawa-shi, Chiba, Japan
	Recruiting
Kisarazu-shi, Chiba, Japan
	Recruiting
Matsudo-shi, Chiba, Japan
	Recruiting
Imabari-shi, Ehime, Japan
	Recruiting
Matsuyama-shi, Ehime, Japan
	Recruiting
Niihama-shi, Ehime, Japan
	Recruiting
Fukui-shi, Fukui, Japan
	Recruiting
Chikushino-shi, Fukuoka, Japan
	Recruiting
Fukuoka-shi, Fukuoka, Japan
	Recruiting
Kasuya-gun, Fukuoka, Japan
	Active, not recruiting
Kitakyushu-shi, Fukuoka, Japan
	Recruiting
Miyako-gun, Fukuoka, Japan
	Recruiting
Onga-gun, Fukuoka, Japan
	Recruiting
Yanagawa-shi, Fukuoka, Japan
	Recruiting
Yukuhashi-shi, Fukuoka, Japan
	Recruiting
Koriyama-shi, Fukushima, Japan
	Recruiting
Gifu-shi, Gifu, Japan
	Recruiting
Takasaki-shi, Gunma, Japan
	Recruiting
Fukuyama-shi, Hiroshima, Japan
	Recruiting
Hatsukaichi-shi, Hiroshima, Japan
	Recruiting
Hiroshima-shi, Hiroshima, Japan
	Recruiting
Asahikawa-shi, Hokkaido, Japan
	Recruiting
Obihiro-shi, Hokkaido, Japan
	Recruiting
Sapporo-shi, Hokkaido, Japan
	Recruiting
Tomakomaki-shi, Hokkaido, Japan
	Recruiting
Kobe-shi, Hyougo, Japan
	Recruiting
Nishinomiya-shi, Hyougo, Japan
	Recruiting
Takarazuka-shi, Hyougo, Japan
	Recruiting
Koga-shi, Ibaragi, Japan
	Recruiting
Tsuchiura-shi, Ibaragi, Japan
	Recruiting
Kanazawa-shi, Ishikawa, Japan
	Recruiting
Komatsu-shi, Ishikawa, Japan
	Recruiting
Nomi-shi, Ishikawa, Japan
	Recruiting
Shiroyama-shi, Ishikawa, Japan
	Recruiting
Takamatsu-shi, Kagawa, Japan
	Recruiting
Ibusuki-shi, Kagoshima, Japan
	Recruiting
Ichikikushikino-shi, Kagoshima, Japan
	Recruiting
Izumi-shi, Kagoshima, Japan
	Recruiting
Atsugi-shi, Kanagawa, Japan
	Recruiting
Kawasaki-shi, Kanagawa, Japan
	Recruiting
Sagamihara-shi, Kanagawa, Japan
	Recruiting
Yokohama-shi, Kanagawa, Japan
	Recruiting
Kochi-shi, Kochi, Japan
	Recruiting
Kumamoto-shi, Kumamoto, Japan
	Recruiting
Kyoto-shi, Kyoto, Japan
	Recruiting
Uji-shi, Kyoto, Japan
	Recruiting
Tsu-shi, Mie, Japan
	Recruiting
Sendai-shi, Miyagi, Japan
	Recruiting
Nagasaki-shi, Nagasaki, Japan
	Recruiting
Nara-shi, Nara, Japan
	Recruiting
Niihama-shi, Niigata, Japan
	Recruiting
Oita-shi, Oita, Japan
	Recruiting
Osaka-shi, Osaka, Japan
	Recruiting
Sakai-shi, Osaka, Japan
	Recruiting
Tondabayashi-shi, Osaka, Japan
	Recruiting
Ageo-shi, Saitama, Japan
	Recruiting
Hiki-gun, Saitama, Japan
	Recruiting
Kumagaya-shi, Saitama, Japan
	Recruiting
Saitama-shi, Saitama, Japan
	Recruiting
Sayama-shi, Saitama, Japan
	Recruiting
Tokorozawa-shi, Saitama, Japan
	Recruiting
Otsu-shi, Shiga, Japan
	Recruiting
Utsunomiya-shi, Tochigi, Japan
	Recruiting
Adachi-ku, Tokyo, Japan
	Recruiting
Hachioji-shi, Tokyo, Japan
	Recruiting
Koto-ku, Tokyo, Japan
	Recruiting
Meguro-ku, Tokyo, Japan
	Recruiting
Minato-ku, Tokyo, Japan
	Recruiting
Shinjuku-ku, Tokyo, Japan
	Recruiting
Tonami-shi, Toyama, Japan
	Recruiting
Toyama-shi, Toyama, Japan
	Recruiting
Iwakuni-shi, Yamaguchi, Japan
	Recruiting
Shimonoseki-shi, Yamaguchi, 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:	NCT01452763 History of Changes
Other Study ID Numbers:	TAK-438/CCT-302, U1111-1123-8746, JapicCTI-111610
Study First Received:	September 16, 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:

Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

Pathologic Processes
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