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
Scientific
Department of Surgery
HPB Unit
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 4250 |
|---|---|
| ajith.siriwardena@cmmc.nhs.uk |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2007 |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Surgery
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
Pharmanord UK Ltd (UK)
Industry
Industry
Telford Court
Morpeth
Northumberland
NE61 2DB
United Kingdom
| Phone | +44 (0)1670 519 989 |
|---|---|
| bhenrikson@pharmanord.co.uk | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
