Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/04/2009
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

Mr Simon Galloway

ORCID ID

Contact details

Department of Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2404/5
Simon.Galloway@smuht.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226121484

Study information

Scientific title

Acronym

Study hypothesis

Either anti-oxidants are of benefit in acute pancreatitis in which case all patients with severe disease should have the benefit of this therapy or they are of no benefit and should no longer be used.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pancreatitis

Intervention

Multi-centre, randomised double-blind placebo-controlled trial:
Group A - Maximal conventional therapy plus intravenous anti-oxidants for 7 days
Group B - Maximal conventional therapy plus placebo

Intervention type

Supplement

Phase

Not Applicable

Drug names

N-acetylcysteine, selenium, vitamin C

Primary outcome measures

Change in multiple organ dysfunction score.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/02/2003

Overall trial end date

03/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

In total 150 patients with predicted severe acute pancreatitis and approx 75 controls will be recruited over the four centres. Approximately 30 patients at SMUHT.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

225

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

03/02/2003

Recruitment end date

03/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

South Manchester University Hospitals NHS Trust (SMUHT) (UK)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/17356040

Publication citations

  1. Results

    Siriwardena AK, Mason JM, Balachandra S, Bagul A, Galloway S, Formela L, Hardman JG, Jamdar S, Randomised, double blind, placebo controlled trial of intravenous antioxidant (n-acetylcysteine, selenium, vitamin C) therapy in severe acute pancreatitis., Gut, 2007, 56, 10, 1439-1444, doi: 10.1136/gut.2006.115873.

Additional files

Editorial Notes