Condition category
Digestive System
Date applied
13/11/2009
Date assigned
04/01/2010
Last edited
04/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv

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

Publication citations

Additional files

Editorial Notes