E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cervical intraepithelial neoplasia grade II/III with positive margin after surgery |
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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 |
Patients with positive margins after surgery for cervical intraepithelial neoplasia (CIN) II/III are at increased risk for residual/recurrent disease. There is no accepted treatment regimen to reduce the number of recurrent/persistent disease. Various studies showed the efficacy of acetyl salicylic acid as chemopreventive agent and treatment option for cancer and its precursors. With respect to cervical dysplasia cyclooxygenase inhibitors, such as acetyl salicylic acid, were shown to be promising for the treatment of CIN. Acetyl salicylic acid is expected to reduce the rate of recurrent/persistent disease after surgery for CIN II/III with positive margins.
Primary outcome parameters: To evaluate whether or not a treatment with acetyl salicylic acid 100mg/day reduces the rate of recurrent/persistent disease after surgery for CIN II/III with positive margins during a 6-month treatment period.
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E.2.2 | Secondary objectives of the trial |
1. To evaluate safety and side-effects of the applied therapy 2. To determine the effect of this drug on human papillomavirus (HPV) viral load in these patients.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Surgery for CIN II/III with positive margins after surgery for CIN II/III with positive margins. 2. Compliant subject 3. Safe contraception
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E.4 | Principal exclusion criteria |
Exclusion Criteria Lesion related 1. (Micro)-Invasive Cancer 2. Non-compliance of patient 3. PAP V
Drug related 1. Prior history of an adverse gastro-intestinal event (ulcer, hemorrhage) 2. Age > 65 3. Concurrent use of a different NSAID 4. Concurrent use of glucocorticoids 5. Concurrent use of anticoagulants 6. Concurrent use of beta-blocker 7. Concurrent use of lithium 8. Concurrent use of diuretics 9. Concurrent use of cyclosporin 10. Concurrent use of methrotrexat 11. Allergic reaction to sulfonamides 12. Allergic reaction after taking NSAIDs 13. Severe kidney problems with decreased renal function 14. Severe liver problems, hepatic disease 15. Uncontrolled hypertension (> 160/90 mmHg) 16. Asthma 17. Allergic reaction to acetyl salicyl acid 18. Hemorrhagic diathesis 19. Thrombocytopenia 20. Hemophilia
Clinical laboratory related Hemoglobin < 11 g/dl Leukocytes < 4,0 x 109/L Platelet count < 100 x 109/L Serum bilirubin > 1.5 x above upper cut-off value Serum GOT > 1.5 x above upper cut-off value Serum GPT > 1.5 x above upper cut-off value Serum alcalic phosphatase > 1.5 x above upper cut-off value Serum creatinine > 1.5 x above cut-off value
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E.5 End points |
E.5.1 | Primary end point(s) |
Abnormal PAP smears during the first years after surgery with positive margins after CIN II/III |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | Yes |
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
| 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |