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

ISRCTN	ISRCTN21047731
DOI	https://doi.org/10.1186/ISRCTN21047731
Protocol serial number	01/06/57 version 9 (date: 21/12/2006)
Sponsor	Pharmanord UK Ltd (UK)
Funder	Pharmanord UK Ltd (UK)

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

Primary study design	Interventional
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.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	Anticipate Trial
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Anti-oxidant therapy (ANTOX version 1.2)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	31/08/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Surgery

Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes