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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000019436 |
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Date of registration:
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21/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone
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Scientific title:
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Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone - Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone |
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Date of first enrolment:
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2015/10/16 |
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Target sample size:
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60 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022471 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Satoshi Ikeda |
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Address:
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Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
Japan |
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Telephone:
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0457019581 |
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Email:
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isatoshi0112@gmail.com |
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Affiliation:
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Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine |
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Name:
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Takashi Ogura |
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Address:
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Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
Japan |
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Telephone:
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0457019581 |
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Email:
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ogura@kanagawa-junko.jp |
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Affiliation:
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Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) AST/ALT/T-bil >= reference value * 2.5 2) The patients who has already received corticosteroid (<=15mg/day), immuno-supressant, NAC, pulmonary vasodilators, and other treatment for IPF 3) Active infection 4) Malignant tumor 5) Other severe complication 6) pregnant or lactating woman 7) severe drug allergy 8) It is determined that it is not suited
Age minimum:
40years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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idiopathic pulmonary fibrosis
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Intervention(s)
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Nintedanib+pirfenidone group; Nintedanib 150mg twice daily Pirfenidone 600-1800mg/day
Nintedanib group; Nintedanib 150mg twice daily
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Primary Outcome(s)
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The ratio of patients who experienced >5% absolute decline in %FVC or death during the first 6-months
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Secondary Outcome(s)
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1) The ratio of patients who experienced >10% absolute decline in %FVC or death during the first 6-months 2) Decline of FVC at 1,3,6,9,12 months 3) The occurence rate of acute excerbation 4) Change in %FVC and %DLco 5) 6 minutes walk test 6) Serum biomarker 7) HRCT findings 8) Toxicity 9) Progression free survival 10) Survival
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Source(s) of Monetary Support
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No funding
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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