Anticipate Trial - Randomized, Double blind, placebo-controlled, multicentre Trial of Anti-oxidant therapy in painful chronic pancreatitis. - Aniticipate trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006958-10-GB

Enrollment

Registered

2007-08-01

Start date

2007-09-26

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Interventions

Product Name: Antox version 1.2 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: There are no secondary objectives.;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.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: There are no secondary objectives.;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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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026