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ISRCTN
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ISRCTN61320108
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ClinicalTrials.gov identifier
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Public title
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Prevention of complications after endoscopic retrograde cholangio-pancreaticography using the antihypertensive drug Cozaar®
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Scientific title
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A randomised controlled trial of the angiotensin II receptor blocker losartan (Cozaar®) in the prevention of hyperenzymemia after endoscopic retrograde cholangio-pancreaticography (ERCP)
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Angiotensin II receptor type 1 blocker prevents post-endoscopic retrograde cholangio-pancreaticography (ERCP) pancreatitis.
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Ethics approval
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Regional Ethical Committee in Stockholm approved on the 12th January 2005 (ref: 2005/1278-31/2)
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Study design
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Triple blinded randomised placebo-controlled multicentre study
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Post-endoscopic retrograde cholangio-pancreaticography pancreatitis
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Participants - inclusion criteria
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1. Patients above 18 years of age, either sex
2. ERCP indicated for diagnostic or therapeutic reasons
3. Informed consent
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Participants - exclusion criteria
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1. Previous ERCP within one year
2. Current elevation of pancreatic amylase and lipase
3. Ongoing acute or chronic pancreatitis
4. Current use of any angiotensin I converting enzyme (ACE) inhibitor or angiotensin II type 1 receptor blocker
5. Bilateral renal artery stenosis or unilateral in case of a single kidney
6. Known hypersensitivity to angiotensin II type 1 receptor blockers
7. Pregnancy
8. Breastfeeding
9. Predefined severe disease (e.g. ongoing sepsis, disseminated intravascular coagulopathy, acute circulatory collapse, severe dehydration, hypovolaemia, severe renal insufficiency or severe liver failure)
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Anticipated start date
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01/04/2006
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Anticipated end date
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31/10/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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Patients are randomised to placebo or 50 mg losartan (Cozaar®) given orally one hour before ERCP. The interventions are given once only; planned follow up is 24 hours.
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Primary outcome measure(s)
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Hyperenzymemia (amylase and or lipase) 24 hours after ERCP
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Secondary outcome measure(s)
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1. Pancreatitis after ERCP defined as abdominal pain persisting more than 24 hours after ERCP and hyperenzymemia defined as three times the upper normal limit
2. Pain measured by the visual analogue scale (VAS) (0 = no pain, 10 = unbearable pain) pre-ERCP and 24 hours after ERCP
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Sources of funding
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1. Swedish Society of Medicine (Sweden)
2. Lisa and Johan Grönberg Foundation (Sweden)
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Trial website
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Publications
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Contact name
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Dr
Mats
Lindblad
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Address
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Upper Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
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City/town
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Stockholm
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Zip/Postcode
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171 76
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Country
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Sweden
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Tel
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+46 (0)8 517 711 43
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Fax
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+46 (0)8 517 762 80
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Email
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mats.lindblad@karolinska.se
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Sponsor
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Karolinska Institutet (Sweden)
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Address
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c/o Jesper Lagergren
Upper Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
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City/town
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Stockholm
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Zip/Postcode
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171 76
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Country
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Sweden
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Tel
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+46 (0)8 517 760 12
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Fax
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+46 (0)8 517 762 80
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Email
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jesper.lagergren@ki.se
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Sponsor website:
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http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv
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Date applied
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13/11/2009
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Last edited
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04/01/2010
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Date ISRCTN assigned
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04/01/2010
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