Condition category
Digestive System
Date applied
05/01/2007
Date assigned
25/01/2007
Last edited
24/09/2012
Prospective/Retrospective
Prospectively 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 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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes