Acetyl salicylic acid in the treatment of patients with positive margins after surgery for cervical dysplasia grade II-III: A phase II trial - Acetyl salicylic acid and CIN II/III non in sano

• Conditions: Cervical intraepithelial neoplasia grade II/III with positive margin after surgery

• Registration Number: EUCTR2004-003944-23-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-16
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 124

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

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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified