Diclofenac for pulmonary embolism

Phase 1

• Conditions: Acute pulmonary embolism; MedDRA version: 14.1Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000247-27-ES
• Lead Sponsor: Fundación Investigación Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Acute symptomatic PE confirmed by multidetector CT angiography, a high-probability V/Q scan, orbythepresence of deep vein trombosis confirmed by lower limb ultrasound testing in patients with non conclusive V/Q scan;
2) first symptoms occurring ten days o rless before randomization;
3) haemodynamic stability (systolic blood pressure> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation o rthrombolytic treatment;
4) right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
5) women of childbearing age should get a negative pregnancy test at screening visit; further agree to use adequate contraception (among them are considered: double barrier as condom + diaphragm, surgical sterilization) within 14 days following administration of study drug.
6) signed informed consent.

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Previous diagnosis of chronic thromboembolic pulmonary hypertension;
2) active bleeding, or clinically relevan tbleeding in the previous month before diagnosis of PE;
4) major surgery, or severe trauma in the previous month before diagnosis of PE;
5) indication for chronic anticoagulation;
6) pregnancy o breast feeding;
7) rena linsufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
8) hypersensitivity to diclofenac, sodium metabisulfite, or acetilsalicilic acid.
7) active Crohn's disease
8) active ulcerative colitis
9) severe heart failure
10) a history of bronchial asthma
11) Patients with severe renal dysfunction
12) Patients with severe hepatic impairment
14) Patients with coagulation disorders.
15) A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal antiinflammatory drugs (NSAIDs)
16) peptic ulcer / active GI bleeding or recurrent (two or more distinct episodes of proven ulceration or bleeding).
17) Severe heart failure

Study & Design

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