E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sporadic colorectal adenomas |
|
E.1.1.1 | Medical condition in easily understood language |
sporadic colorectal adenomatous polyps |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069428 |
E.1.2 | Term | Colon adenomatous polyp |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on apoptosis and proliferation in histologically normal sigmoid and rectal mucosa relative to the placebo group. |
|
E.2.2 | Secondary objectives of the trial |
Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on expression of β-catenin signalling pathway components in histologically normal sigmoid and rectal mucosa relative to the placebo group. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- having undergone complete colonoscopy with polypectomy, within 6 months of study entry, for removal of at least 2 colorectal adenomas, irrespective of size, and/or 1 colorectal adenoma with at least one of the following features: diameter of at least 1 cm, proximal localization, high-grade dysplasia or villous aspects.
- age 50-75 years
|
|
E.4 | Principal exclusion criteria |
- inflammatory bowel disease
- familial colorectal cancer syndrome
- history of colorectal carcinoma
- history of surgery to the large bowel (except appendectomy)
- chronic renal insufficiency
- chronic hepatic insufficiency
- allergy to salicylates
- diabetes mellitus
- coagulation disorder or anticoagulant use, which cannot be temporarily discontinued
- asthma
- regular intake of one or more of the following immunosuppressants: thiopurines, methotrexate or cyclosporin
- prescription use of aspirin (high- and low-dose) and other NSAIDs
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The effect of treatment with mesalazine on apoptotic and proliferation indices relative to the placebo group. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
before treatment and after 6 months of treatment |
|
E.5.2 | Secondary end point(s) |
The effect of treatment with mesalazine on the expression of beta-catenin signalling pathway components relative to the placebo group. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
before treatment and after 6 months of treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
|
last visit of the last subject undergoing the trial |
|
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 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |