Contact information
Type
Scientific
Primary contact
Mr Ajith Siriwardena
ORCID ID
Contact details
Department of Surgery
HPB Unit
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 4250
ajith.siriwardena@cmmc.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/06/57 version 9 (date: 21/12/2006)
Study information
Scientific title
Acronym
Anticipate Trial
Study hypothesis
This study is designed to test the principal hypothesis that anti-oxidant therapy with ANTOX version 1.2 reduces pain in patients with painful chronic pancreatitis.
Ethics approval
Approval will be submitted to the Local Ethical Committee (North West MREC) on the 13th February 2007 (Project No. 07/MRE08/13).
Study design
The study will take the form of a double-blind, placebo-controlled, multi-centre randomised trial of ANTOX version 1.2 in patients with painful chronic pancreatitis.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic pancreatitis
Intervention
We would be using intravenous blood sample for routine clinical Haematology/Bio-chemistry. Total dose of the treatment is two tablets three times a day for six months. Each tablet will be weighing 1145 mg (both Antox and placebo).
1. Pathological test: routine haematology and biochemistry
2. Face to face interview: with subjects enrolling in the trial
Intervention type
Drug
Phase
Not Specified
Drug names
Anti-oxidant therapy (ANTOX version 1.2)
Primary outcome measure
Each patient enrolled in the study will contribute pain scores at baseline and six months from which a change in pain score will be calculated. The primary endpoint will be the difference in change scores between treatment and control groups. The use of change rather than endpoint scores is important given the likely considerable interpersonal variation in the use of pain scales and thus removes interpersonal variance.
Secondary outcome measures
1. Time in pain assessed as the area under the curve of pain scores assessed at baseline, two, four and six months
2. Quality of life scores compared at enrolment to those at two, four and six months using disease specific measure (EORTC-QLQC30 and QLQ-PAN26) and a generic measure (EuroQOL EQ-5D)
3. Opiate usage (defined as morphine equivalents) assessed monthly over the six-month period of the study and analysed using repeated measures design
4. Incidence of specific pancreatitis-related complications: hospital admission with acute exacerbation of chronic pancreatitis or for pain control (defined from hospital discharge notes) and specific pancreatitis-related complications (pancreatic pseudocyst defined according to Atlanta consensus conference criteria) and pancreatic abscess
5. Economic analysis including use of anti-oxidant therapy and hospital-based resource utilisation associated with chronic pancreatitis
6. Assessment of any treatment-related side effects and complications
Overall trial start date
01/02/2007
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Ability to give informed consent
2. Age over 18 years
3. Computed Tomography (CT) within three months of trial enrolment
4. Either CT and/or Endoscopic Retrograde CholangioPancreatography (ERCP) or Magnetic Resonance (MR) evidence of chronic pancreatitis
5. CT and either ERCP or MR evidence to exclude pancreatic carcinoma with tests having been undertaken within three months of enrolment
6. Baseline median daily visual analogue pain score greater than five (on a ten point score) for at least seven days in a pre-randomisation run-in period of four weeks
7. Completion of daily visual analogue score-based pain diaries in the four week period preceding randomisation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Not meeting inclusion criteria
2. Inability to give informed consent
3. Inability to comply with trial protocol
4. Patients with chronic renal failure (with a creatinine clearance of less than 50 ml/minute)
5. Patients who are pregnant or lactating or who plan to become pregnant during the study period
6. Patients who are participating in another trial
7. Patients who are already taking antioxidants
8. Patients with schizophrenia
Recruitment start date
01/02/2007
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Pharmanord UK Ltd (UK)
Sponsor details
Telford Court
Morpeth
Northumberland
NE61 2DB
United Kingdom
+44 (0)1670 519 989
bhenrikson@pharmanord.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmanord UK Ltd (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
Basic results (scientific)
Publication list
1. 2010 quality of life results in http://www.ncbi.nlm.nih.gov/pubmed/20731021
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22683257
Publication citations
-
Quality of life results
Shah NS, Makin AJ, Sheen AJ, Siriwardena AK, Quality of life assessment in patients with chronic pancreatitis receiving antioxidant therapy., World J. Gastroenterol., 2010, 16, 32, 4066-4071.
-
Results
Siriwardena AK, Mason JM, Sheen AJ, Makin AJ, Shah NS, Antioxidant therapy does not reduce pain in patients with chronic pancreatitis: the ANTICIPATE study., Gastroenterology, 2012, 143, 3, 655-63.e1, doi: 10.1053/j.gastro.2012.05.046.