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Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

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ClinicalTrials.gov Identifier: NCT02099682
Recruitment Status : Completed
First Posted : March 31, 2014
Results First Posted : June 25, 2015
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Gastric or Duodenal Ulcers
Intervention Drug: Lansoprazole
Enrollment 3366
Recruitment Details Participants took part in the study at 460 investigative sites in Japan from August 2010 to January 2014 (N=3366).
Pre-assignment Details Patients with a history of gastric or duodenal ulcers and requiring long-term use of low-dose aspirin were enrolled in the study.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description Lansoprazole 15 mg orally once daily
Period Title: Overall Study
Started 3366 [1]
Safety Analysis Set (SAS) 3255 [2]
Completed 3255
Not Completed 111
Reason Not Completed
Data Not Available             51
Lost to Follow-up             31
Other             29
[1]
Number of cases.
[2]
All participants who took the study drug at least once.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description Lansoprazole 15 mg orally once daily
Overall Number of Baseline Participants 3255
Hide Baseline Analysis Population Description
Safety analysis set: all participants who took the study drug at least once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3255 participants
72.4  (11.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3255 participants
Female
1399
  43.0%
Male
1856
  57.0%
Purpose for Low-Dose Aspirin Use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3255 participants
Angina pectoris 1182
Myocardial infarction 531
Transient ischaemic attack (TIA) 221
Cerebral infarction 1225
Post-coronary artery bypass (CABG) 106
PTCA 398
Other 316
[1]
Measure Description: Participants could be counted in more than 1 category.
Gastric or Duodenal Ulcer History Breakdown   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3255 participants
Gastric ulcer 2718
Duodenal ulcer 313
Unknown 252
[1]
Measure Description: Participants could be counted in more than 1 category.
Gastric or Duodenal Ulcer History: Time of Onset  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3255 participants
Within 6 months of study drug administration 213
≥ 6 months, < 1 year before start of treatment 138
1 year or longer before the start of treatment 977
Unknown 1927
H. pylori infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3255 participants
Negative 425
Positive 171
Unknown 2659
1.Primary Outcome
Title Frequency of Adverse Drug Reactions
Hide Description Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set - All participants who received at least 1 dose of lansoprazole.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3255
Measure Type: Number
Unit of Measure: participants
Enteritis infectious 1
Lymphoma 1
Diabetes mellitus 1
Anxiety 1
Dizziness 2
Dysgeusia 1
Headache 1
Loss of consciousness 1
Sudden hearing loss 1
Abdominal discomfort 1
Abdominal distension 1
Abdominal pain 1
Colitis 1
Constipation 2
Diarrhoea 23
Enterocolitis 1
Gastrooesophageal reflux disease 1
Haematochezia 1
Nausea 4
Colitis microscopic 3
Hypoaesthesia oral 1
Faeces soft 1
Drug eruption 3
Eczema 1
Hypersensitivity vasculitis 1
Pruritus 1
Rash generalised 1
Back pain 1
Osteoporosis 1
Renal failure chronic 1
Sudden death 1
Thirst 1
Hepatic enzyme increased 1
Glycosylated haemoglobin increased 1
Weight decreased 1
Fall 1
Spinal fracture 1
2.Secondary Outcome
Title Presence or Absence of Endoscopic Examinations
Hide Description Summary of data on the presence or absence of endoscopic examinations.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
With endoscopy 2773
Without endoscopy 437
3.Secondary Outcome
Title Presence of Gastric or Duodenal Ulcer
Hide Description Summary of data on the presence or absence of gastric or duodenal ulcers.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Present 3190
Absent 20
4.Secondary Outcome
Title Presence of Gastric or Duodenal Hemorrhagic Lesion
Hide Description Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Present 3201
Absent 9
5.Secondary Outcome
Title Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
Hide Description Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Present 3186
Absent 24
6.Secondary Outcome
Title Treatment for Gastric/Duodenal Ulcer or Lesion
Hide Description Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Present 0
Absent 24
7.Secondary Outcome
Title Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Hide Description Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Takepron Capsule or OD Tablet 15 mg 15
Takepron Capsule or OD Tablet 30 mg 2
Rabeprazole tablet 10 mg 2
H2 receptor antagonist (oral) 1
Omeprazole (injection) 2
H2 receptor antagonist (injection) 1
Other peptic ulcer drugs 2
Endoscopic hemostasis 1
Other 5
8.Secondary Outcome
Title Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Hide Description Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Time Frame From baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description:
Lansoprazole 15 mg orally once daily
Overall Number of Participants Analyzed 3210
Measure Type: Number
Unit of Measure: participants
Takepron 15 mg: Recovery 9
Takepron 15 mg: Relief 6
Takepron 30 mg: Recovery 1
Takepron 30 mg: Relief 1
Rabeprazole 10 mg: Recovery 1
Rabeprazole 10 mg: Relief 1
H2 receptor antagonist (orally): Recovery 1
H2 receptor antagonist (orally): Relief 1
Omeprazole (injection): Recovery 1
Omeprazole (injection): Relief 1
H2 receptor antagonist (injection): Recovery 2
H2 receptor antagonist (injection): Relief 1
Other peptic ulcer drugs: Recovery 3
Other peptic ulcer drugs: Relief 2
Endoscopic hemostasis: Recovery 9
Endoscopic hemostasis: Relief 6
Other: Recovery 1
Other: Relief 1
Time Frame From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open-label study drug (up to 12 months).
Adverse Event Reporting Description Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
 
Arm/Group Title Lansoprazole 15 mg
Hide Arm/Group Description Lansoprazole 15 mg orally once daily
All-Cause Mortality
Lansoprazole 15 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lansoprazole 15 mg
Affected / at Risk (%)
Total   126/3225 (3.91%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation  1  1/3225 (0.03%) 
Cardiac disorders   
Angina pectoris  1  4/3225 (0.12%) 
Angina unstable  1  2/3225 (0.06%) 
Aortic valve stenosis  1  1/3225 (0.03%) 
Atrial fibrillation  1  2/3225 (0.06%) 
Cardiac failure  1  8/3225 (0.25%) 
Cardiac failure acute  1  2/3225 (0.06%) 
Cardiac failure congestive  1  6/3225 (0.19%) 
Myocardial infarction  1  5/3225 (0.16%) 
Ventricular arrhythmia  1  1/3225 (0.03%) 
Acute coronary syndrome  1  1/3225 (0.03%) 
Cardiac failure chronic  1  1/3225 (0.03%) 
Ear and labyrinth disorders   
Sudden hearing loss  1  1/3225 (0.03%) 
Eye disorders   
Cataract  1  1/3225 (0.03%) 
Gastrointestinal disorders   
Abdominal pain  1  1/3225 (0.03%) 
Colitis ischaemic  1  2/3225 (0.06%) 
Diarrhoea  1  2/3225 (0.06%) 
Gastric polyps  1  1/3225 (0.03%) 
Gastric ulcer  1  1/3225 (0.03%) 
Gastritis  1  1/3225 (0.03%) 
Ileal ulcer  1  1/3225 (0.03%) 
Inguinal hernia  1  1/3225 (0.03%) 
Intestinal obstruction  1  1/3225 (0.03%) 
Melaena  1  1/3225 (0.03%) 
Pancreatitis acute  1  1/3225 (0.03%) 
Rectal ulcer  1  1/3225 (0.03%) 
Large intestine polyp  1  1/3225 (0.03%) 
Alcoholic pancreatitis  1  1/3225 (0.03%) 
Haemorrhagic erosive gastritis  1  1/3225 (0.03%) 
General disorders   
Death  1  2/3225 (0.06%) 
Oedema peripheral  1  1/3225 (0.03%) 
Pyrexia  1  1/3225 (0.03%) 
Sudden death  1  1/3225 (0.03%) 
Sudden cardiac death  1  1/3225 (0.03%) 
Accidental device ingestion  1  1/3225 (0.03%) 
Hepatobiliary disorders   
Bile duct stone  1  1/3225 (0.03%) 
Cholecystitis  1  2/3225 (0.06%) 
Cholelithiasis  1  1/3225 (0.03%) 
Hepatic function abnormal  1  1/3225 (0.03%) 
Liver disorder  1  1/3225 (0.03%) 
Infections and infestations   
Appendicitis  1  1/3225 (0.03%) 
Gastroenteritis  1  1/3225 (0.03%) 
Pneumonia  1  9/3225 (0.28%) 
Pyelonephritis  1  2/3225 (0.06%) 
Sepsis  1  1/3225 (0.03%) 
Urinary tract infection  1  1/3225 (0.03%) 
Injury, poisoning and procedural complications   
Failure to anastomose  1  1/3225 (0.03%) 
Fall  1  2/3225 (0.06%) 
Femoral neck fracture  1  1/3225 (0.03%) 
Femur fracture  1  1/3225 (0.03%) 
Road traffic accident  1  2/3225 (0.06%) 
Subdural haematoma  1  1/3225 (0.03%) 
Traumatic ulcer  1  1/3225 (0.03%) 
Traumatic fracture  1  1/3225 (0.03%) 
Skull fracture  1  1/3225 (0.03%) 
Musculoskeletal and connective tissue disorders   
Muscle haemorrhage  1  1/3225 (0.03%) 
Spinal osteoarthritis  1  1/3225 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bile duct cancer  1  1/3225 (0.03%) 
Breast cancer  1  1/3225 (0.03%) 
Colon cancer  1  4/3225 (0.12%) 
Gastric cancer  1  4/3225 (0.12%) 
Lymphoma  1  2/3225 (0.06%) 
Rectal cancer  1  1/3225 (0.03%) 
Uterine cancer  1  1/3225 (0.03%) 
Colon adenoma  1  1/3225 (0.03%) 
Lung neoplasm malignant  1  4/3225 (0.12%) 
Non-small cell lung cancer  1  1/3225 (0.03%) 
Hepatocellular carcinoma  1  1/3225 (0.03%) 
Nervous system disorders   
Carotid artery stenosis  1  1/3225 (0.03%) 
Cerebellar infarction  1  1/3225 (0.03%) 
Cerebral haemorrhage  1  2/3225 (0.06%) 
Cerebral infarction  1  5/3225 (0.16%) 
Convulsion  1  1/3225 (0.03%) 
Dyslalia  1  1/3225 (0.03%) 
Epilepsy  1  1/3225 (0.03%) 
Hemiparesis  1  1/3225 (0.03%) 
Intracranial aneurysm  1  1/3225 (0.03%) 
Thrombotic cerebral infarction  1  1/3225 (0.03%) 
Psychiatric disorders   
Agitation  1  1/3225 (0.03%) 
Psychosomatic disease  1  1/3225 (0.03%) 
Renal and urinary disorders   
Renal failure acute  1  1/3225 (0.03%) 
Renal impairment  1  1/3225 (0.03%) 
Reproductive system and breast disorders   
Breast mass  1  1/3225 (0.03%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/3225 (0.03%) 
Chronic obstructive pulmonary disease  1  1/3225 (0.03%) 
Chronic respiratory failure  1  1/3225 (0.03%) 
Emphysema  1  1/3225 (0.03%) 
Interstitial lung disease  1  1/3225 (0.03%) 
Pleural effusion  1  1/3225 (0.03%) 
Pneumonia aspiration  1  5/3225 (0.16%) 
Skin and subcutaneous tissue disorders   
Hypersensitivity vasculitis  1  1/3225 (0.03%) 
Surgical and medical procedures   
Coronary angioplasty  1  1/3225 (0.03%) 
Enterostomy  1  1/3225 (0.03%) 
Vascular disorders   
Aortic aneurysm rupture  1  3/3225 (0.09%) 
Aortic dissection  1  1/3225 (0.03%) 
Hypotension  1  1/3225 (0.03%) 
Aortic rupture  1  1/3225 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lansoprazole 15 mg
Affected / at Risk (%)
Total   0/3255 (0.00%) 
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, Clinical Science
Organization: Takeda
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02099682     History of Changes
Other Study ID Numbers: 467-712
JapicCTI-142414 ( Registry Identifier: JapicCTI )
JapicCTI-R150735 ( Registry Identifier: JapicCTI )
First Submitted: March 26, 2014
First Posted: March 31, 2014
Results First Submitted: June 5, 2015
Results First Posted: June 25, 2015
Last Update Posted: November 4, 2016