Randomised double-blind, placebo-controlled multicentre trial of antioxidant therapy in painful chronic pancreatitis

ISRCTN ISRCTN21047731
DOI https://doi.org/10.1186/ISRCTN21047731
Secondary identifying numbers 01/06/57 version 9 (date: 21/12/2006)
Submission date
05/01/2007
Registration date
25/01/2007
Last edited
24/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ajith Siriwardena
Scientific

Department of Surgery
HPB Unit
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone +44 (0)161 276 4250
Email ajith.siriwardena@cmmc.nhs.uk

Study information

Study designThe 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymAnticipate Trial
Study objectivesThis 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(s)Approval will be submitted to the Local Ethical Committee (North West MREC) on the 13th February 2007 (Project No. 07/MRE08/13).
Health condition(s) or problem(s) studiedChronic pancreatitis
InterventionWe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Anti-oxidant therapy (ANTOX version 1.2)
Primary outcome measureEach 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 measures1. 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 study start date01/02/2007
Completion date31/08/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2007
Date of final enrolment31/08/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Surgery
Manchester
M13 9WL
United Kingdom

Sponsor information

Pharmanord UK Ltd (UK)
Industry

Telford Court
Morpeth
Northumberland
NE61 2DB
United Kingdom

Phone +44 (0)1670 519 989
Email bhenrikson@pharmanord.co.uk
ROR logo "ROR" https://ror.org/00hz19x62

Funders

Funder type

Industry

Pharmanord UK Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article quality of life results 28/08/2010 Yes No
Results article results 01/09/2012 Yes No