Contact information
Type
Scientific
Primary contact
Dr Mats Lindblad
ORCID ID
Contact details
Upper Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
Stockholm
171 76
Sweden
+46 (0)8 517 711 43
mats.lindblad@karolinska.se
Additional identifiers
EudraCT number
2005-004545-34
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of the angiotensin II receptor blocker losartan (Cozaar®) in the prevention of hyperenzymemia after endoscopic retrograde cholangio-pancreaticography (ERCP)
Acronym
Study hypothesis
Angiotensin II receptor type 1 blocker prevents post-endoscopic retrograde cholangio-pancreaticography (ERCP) pancreatitis.
Ethics approval
Regional Ethical Committee in Stockholm approved on the 12th January 2005 (ref: 2005/1278-31/2)
Study design
Triple blinded randomised placebo-controlled multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-endoscopic retrograde cholangio-pancreaticography pancreatitis
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Losartan (Cozaar®)
Primary outcome measures
Hyperenzymemia (amylase and or lipase) 24 hours after ERCP
Secondary outcome measures
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
Overall trial start date
01/04/2006
Overall trial end date
31/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients above 18 years of age, either sex
2. ERCP indicated for diagnostic or therapeutic reasons
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
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)
Recruitment start date
01/04/2006
Recruitment end date
31/10/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Upper Gastrointestinal Research Group (UGIR)
Stockholm
171 76
Sweden
Sponsor information
Organisation
Karolinska Institutet (Sweden)
Sponsor details
c/o Jesper Lagergren
Upper Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
Stockholm
171 76
Sweden
+46 (0)8 517 760 12
jesper.lagergren@ki.se
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Swedish Society of Medicine (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lisa and Johan Grönberg Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary