Clinical trial NCT01505127: Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
Official title: A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: H. Pylori Infection
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-01-06
Enrollment: 650
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 confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.


Eligibility criteria: Inclusion Criteria:

1. Participants must be H. pylori-positive patients at baseline (Visit 1)
2. Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).

   However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
3. Outpatient (including inpatient for examination)

Exclusion Criteria:

1. Participants who have received H.pylori eradication treatment
2. Participants who have either acute upper gastrointestinal bleeding, gastric ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], duodenal ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).

   However, participants with gastric erosion or duodenal erosion may be included in the study.
3. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
4. Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. Participants with hepatic or renal impairment receiving treatment with colchicines
7. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
8. Participants with infectious mononucleosis
9. Participants with an organic disease of the brain or spinal cord

Primary outcomes:
measure: H. pylori eradication rate 4 weeks after completion of first-line therapy
timeFrame: 4-weeks post-dose (first-line therapy)
Secondary outcomes:
measure: H. pylori eradication rate 4 weeks after completion of second-line therapy
timeFrame: 4-weeks post-dose (second-line therapy)
Other outcomes:
Locations:
city: Abiko-shi
country: Japan
state: Chiba
city: Kashiwa-shi
country: Japan
state: Chiba
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Ishikari-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyogo
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Marugame-shi
country: Japan
state: Kagawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Ebina-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Yatsushiro-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Oita-shi
country: Japan
state: Oita
city: Hirakata-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: Kumagaya-shi
country: Japan
state: Saitama
city: Tokorozawa-shi
country: Japan
state: Saitama
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Adachi-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Hachioji-shi
country: Japan
state: Tokyo
city: Kokubunji-shi
country: Japan
state: Tokyo
city: Nishi-tokyo-shi
country: Japan
state: Tokyo
city: Oota-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.