E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Chronic pancreatitis (CP) is a chronic inflammatory condition of the pancreas characterized by recurrent abdominal pain. There is at present no specific medication for this condition. It is known that anti-oxidants are depleted in chronic pancreatitis. There is anecdotal evidence that anti-oxidant supplementation leads to reduction in pain in patients with chronic pancreatitis (probably by restoration of cellular maintenance pathways). In our unit, the commercially available preparation Antox (Pharmanord, Morpeth, UK) is used to treat patients with CP. However, there is really no strong evidence to show benefit from treatment and the purpose of this study is to conduct a randomized, double-blind, placebo-controlled evaluation of the role of antox in patients with CP to assess whether treatment is associated with a reduction in pain and an improvement in quality of life. |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for Patients with CP
. Ability to give informed consent . Age over 18 years . CT within 3 months of trial enrolment. . Either CT and/or ERCP or MR evidence of CP. . CT and either ERCP or MR evidence to exclude pancreatic carcinoma with tests having been undertaken within 3 months of enrolment. . Baseline median daily visual analogue pain score greater than 5 for at least 7 days in a pre-randomization run-in period of 4 weeks. . Completion of daily visual analogue score-base pain diaries in the four week period preceding randomization.
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E.4 | Principal exclusion criteria |
Exclusion criteria
. Not meeting inclusion criteria. . Inability to give informed consent. . Inability to comply with trial protocol. . Patients with Chronic renal failure. . Patients with Schizophrenia (methionine - a constituent of antox can precipitate psychosis in patients with schizophrenia) (ref). . Patients who are pregnant or lactating or who plan to become pregnant during the study period . Patients who are participating in another trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Each patient enrolled in the study will contribute pain scores at baseline and 6 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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At the end of the trial patients randomized to the intervention arm who report subjective improvement will be offered the opportunity to continue therapy. Placebo intervention will not be continued after the 6 month trial period but patients in this arm who remain symptomatic will be offered the option of commencing ANTOX therapy pending final analysis of results.
All patients will be continued to be followed up for routine clinical care and management.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |