Pharmacological modulation of inflammation and platelet activation in inflammatory bowel diseases

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2013-002143-29-IT
• Lead Sponsor: POLICLINICO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Will be including in this study patients of both sexes, with RCU or MC in remission or mild clinical activity, over the age of 18 years
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Indication for cardiovascular prevention with aspirin and other antiplatelet agents, contraindications or allergy to aspirin, allergic asthma, pregnancy, smoking, uncontrolled hypercholesterolemia, renal disease (creatinine over 2 mg/dl), uncontrolled hypertension, skin and mocous bleeding history, thrombocytopenia (PLT < 60000/µl), severe anemia (Hb < 8 g/dl), coagulation disorders, gastritis, peptic ulcer disease history, gastroesophageal reflux disease, esophageal and / or gastroduodenal sites of disease, previous gastrointestinal surgery, biologic drug treatment, methotrexate, azathioprine or other immunosuppressive agents, coxibs and NSAIDs treatment. Analgesic acetaminophen will be allowed, at doses not exceeding 500 mg twice a day. It will also be permitted 5-aminosalicylic acid (mesalamine) administration. Steroid-resistant or steroid-dependent patients will be excluded.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: investigate in patients with inflammarory bowel diseases the existence of a state of platelet activation in vivo, its contribution to chronic inflammation and its possible pharmacological modulation by low dose aspirin.;Secondary Objective: nd;Primary end point(s): Will be used biochemical end-points, serum TXB2 and urinary 11-dehydro-TXB2, the main in vitro and in vivo markers of thromboxane-dependent platelet activation respectively.;Timepoint(s) of evaluation of this end point: 14 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na