Clinical trial NCT01452724: Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
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 Duodenal Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Duodenal Ulcer
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 372
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 efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.


Eligibility criteria: Inclusion Criteria:

1. Participants must have endoscopically confirmed duodenal 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).
2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)

Primary outcomes:
measure: Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
timeFrame: 4 weeks
measure: Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
timeFrame: 2 weeks
measure: Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Toyota-shi
country: Japan
state: Aichi
city: Kamagaya-shi
country: Japan
state: Chiba
city: Kisarazu-shi
country: Japan
state: Chiba
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Kurume-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Tagawa-shi
country: Japan
state: Fukuoka
city: Yanagawa-shi
country: Japan
state: Fukuoka
city: Yukuhashi-shi
country: Japan
state: Fukuoka
city: Sappori-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyogo
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Takarazuka-shi
country: Japan
state: Hyogo
city: Hitachi-shi
country: Japan
state: Ibaraki
city: Hitacinaka-shi
country: Japan
state: Ibaraki
city: Marugame-shi
country: Japan
state: Kagawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Kanoya-shi
country: Japan
state: Kagoshima
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Yashiro-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Sasebo-shi
country: Japan
state: Nagasaki
city: Oita-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Shimajiri-gun
country: Japan
state: Okinawa
city: Daito-shi
country: Japan
state: Osaka
city: Fujiidera-shi
country: Japan
state: Osaka
city: Hirakata-shi
country: Japan
state: Osaka
city: Kishiwada-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Takatsuki-shi
country: Japan
state: Osaka
city: Toyonaka-shi
country: Japan
state: Osaka
city: Saga-shi
country: Japan
state: Saga
city: Ageo-shi
country: Japan
state: Saitama
city: Kumagaya-shi
country: Japan
state: Saitama
city: Tokorozawa-shi
country: Japan
state: Saitama
city: Otsu-shi
country: Japan
state: Shiga
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Ashikaga-shi
country: Japan
state: Tochigi
city: Otawara-shi
country: Japan
state: Tochigi
city: Shimotsuga-gun
country: Japan
state: Tochigi
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Tokushima-shi
country: Japan
state: Tokushima
city: Hachioji-shi
country: Japan
state: Tokyo
city: Kodaira-shi
country: Japan
state: Tokyo
city: Kokubunji-shi
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Mitaka-shi
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Wakayama-shi
country: Japan
state: Wakayama
city: Yamagata-shi
country: Japan
state: Yamagata
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Kofu-shi
country: Japan
state: Yamanashi
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.