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

Completed

• Conditions: Chronic pancreatitis; Digestive System; Pancreatitis

• Registration Number: ISRCTN21047731
• Lead Sponsor: Pharmanord UK Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Time in pain assessed as the area under the curve of pain scores assessed at baseline, two, four and six months<br>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)<br>3. Opiate usage (defined as morphine equivalents) assessed monthly over the six-month period of the study and analysed using repeated measures design<br>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<br>5. Economic analysis including use of anti-oxidant therapy and hospital-based resource utilisation associated with chronic pancreatitis<br>6. Assessment of any treatment-related side effects and complications