Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 62 of 938 for:    tablet | Japan

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219723
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Interventions Drug: Vonoprazan
Drug: Amoxicillin hydrate
Drug: Clarithromycin
Drug: Metronidazole
Enrollment 560
Recruitment Details Participants took part in the study at 58 investigative sites in Japan, from 01 September 2015 to 30 April 2017.
Pre-assignment Details Participants with a historical diagnosis of gastric/duodenal ulcer, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis were enrolled to receive interventions as part of routine medical care. However, participants with gastric MALT lymphoma were not enrolled in the survey.
Arm/Group Title Vonoprazan 20 mg
Hide Arm/Group Description For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
Period Title: Overall Study
Started 560
Completed 550
Not Completed 10
Reason Not Completed
Case Report Forms Uncollected             6
Protocol Deviation             4
Arm/Group Title Vonoprazan 20 mg
Hide Arm/Group Description For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
Overall Number of Baseline Participants 550
Hide Baseline Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 550 participants
58.7  (13.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Female
293
  53.3%
Male
257
  46.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 550 participants
550
Trial Indications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Gastric Ulcer Number Analyzed 550 participants
50
   9.1%
Duodenal Ulcer Number Analyzed 550 participants
31
   5.6%
Idiopathic Thrombocytopenic Purpura Number Analyzed 550 participants
12
   2.2%
Stomach Following Endoscopic Treatment of EGC Number Analyzed 550 participants
12
   2.2%
H. Pylori Gastritis Number Analyzed 550 participants
476
  86.5%
[1]
Measure Description: EGC=Early Gastric Cancer. Participants could be counted in more than 1 category (including duplicates).
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Outpatient
546
  99.3%
Inpatient
4
   0.7%
[1]
Measure Description: Participants were categorized as outpatient, inpatient.
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Had Predisposition to Hypersensitivity
16
   2.9%
Had No Predisposition to Hypersensitivity
518
  94.2%
Unknown
16
   2.9%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Had Presence of Medical Complications
232
  42.2%
Had No Presence of Medical Complications
318
  57.8%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Pre-Therapy of H. Pylori Eradication before Study   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
PPI + AMPC + CAM 400 mg
7
  14.6%
PPI + AMPC + CAM 800 mg
27
  56.3%
Vonoprazan + AMPC + CAM 400 mg
4
   8.3%
Vonoprazan + AMPC + CAM 800 mg
7
  14.6%
Unknown
3
   6.3%
[1]
Measure Analysis Population Description: Reported data was the number of participants who H. pylori eradication has been unsuccessful in pre-treatment by Vonoprazan or PPI, AMPC and CAM before this study (totally 48 participants).
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 306 participants
160.62  (9.148)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 318 participants
59.63  (11.377)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
BMI   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 304 participants
23.03  (3.481)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Never Smoked
266
  48.4%
Current Smoker
67
  12.2%
Ex-Smoker
68
  12.4%
Unknown
149
  27.1%
Drinking Habits   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
Yes
118
  21.5%
No
302
  54.9%
Unknown
130
  23.6%
[1]
Measure Description: Participants who answered Yes or No for a question “Drink Alcohol Almost Every Day?" were reported.
Diagnostic Test for H. Pylori Infection   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Rapid Urease Test Number Analyzed 550 participants
103
  18.7%
Microscopy Number Analyzed 550 participants
43
   7.8%
Culture Method Number Analyzed 550 participants
26
   4.7%
Urea Breath Test Number Analyzed 550 participants
167
  30.4%
Anti-H. Pylori Antibody Test Number Analyzed 550 participants
209
  38.0%
Stool H. Pylori Antigen Test Number Analyzed 550 participants
12
   2.2%
[1]
Measure Description: Participants could be counted in more than 1 category (including duplicates).
Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants
First-Line Eradication
502
  91.3%
Second-Line Eradication
48
   8.7%
1.Primary Outcome
Title Percentage of Participants Who Had One or More Adverse Drug Reactions
Hide Description Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Time Frame Up to 7 days and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Vonoprazan 20 mg
Hide Arm/Group Description:
For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 550
Measure Type: Number
Unit of Measure: Percentage of Participants
3.09
2.Secondary Outcome
Title H. Pylori Eradication Rate
Hide Description In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Time Frame 7 days + 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
Arm/Group Title Vonoprazan 20 mg
Hide Arm/Group Description:
For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent
First-Line Eradication Number Analyzed 469 participants
91.24
(88.30 to 93.64)
Second-Line Eradication Number Analyzed 44 participants
95.45
(84.53 to 99.44)
Time Frame Up to 7days and 2 months
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Vonoprazan 20 mg
Hide Arm/Group Description For adults, the following three-drug regimen was administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin allowed to be increased as clinically warranted. However, dosage was not to exceed 400 mg (potency)/ dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin had been unsuccessful, as an alternative treatment, the following three-drug regimen was administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants received interventions as part of routine medical care.
All-Cause Mortality
Vonoprazan 20 mg
Affected / at Risk (%)
Total   0/550 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vonoprazan 20 mg
Affected / at Risk (%)
Total   0/550 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vonoprazan 20 mg
Affected / at Risk (%)
Total   22/550 (4.00%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/550 (0.18%) 
Abdominal distension  1  1/550 (0.18%) 
Constipation  1  1/550 (0.18%) 
Diarrhoea  1  4/550 (0.73%) 
Faeces hard  1  1/550 (0.18%) 
Ileus  1  1/550 (0.18%) 
Nausea  1  5/550 (0.91%) 
Vomiting  1  1/550 (0.18%) 
Paraesthesia oral  1  1/550 (0.18%) 
Faeces soft  1  2/550 (0.36%) 
General disorders   
Malaise  1  1/550 (0.18%) 
Hepatobiliary disorders   
Liver disorder  1  1/550 (0.18%) 
Infections and infestations   
Influenza  1  1/550 (0.18%) 
Nervous system disorders   
Dizziness  1  1/550 (0.18%) 
Dysgeusia  1  3/550 (0.55%) 
Hypogeusia  1  1/550 (0.18%) 
Skin and subcutaneous tissue disorders   
Drug eruption  1  2/550 (0.36%) 
Eczema  1  1/550 (0.18%) 
Rash  1  2/550 (0.36%) 
Urticaria  1  1/550 (0.18%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03219723     History of Changes
Other Study ID Numbers: Vonoprazan-5002
JapicCTI-153003 ( Registry Identifier: JapicCTI )
First Submitted: July 9, 2017
First Posted: July 17, 2017
Results First Submitted: April 27, 2018
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019