Clinical trial to evaluate, in patient suffering of neck pain the therapeutic equivalence, tolerability and satisfaction of subjects treated by medicated plaster containing piroxicam or diclofenac. - PIR-BO-11-001

S.P.A. ITALIANA LABORATORI BOUTY0 sitesJune 22, 2012

Overview

No summary available.

Registry

who.int

Start Date

June 22, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

S.P.A. ITALIANA LABORATORI BOUTY

•1\. Diagnosis of cervical pain 2\. Male or female aged between 18 and 75 years with a diagnosis of cervical pain(With pain greater than 30 mm on the VAS scale from 0 to 100 mm). 3\. Be followed by general practitioners. 4\. Being able to read, understand and sign informed consent approved by the Ethics Committee. 5\. Accept and be able to fill in the diary study and the VAS
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 120
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 120

•1\. Patients with cervical disc disease or due to trauma. 2\. Presence of skin lesions in the area of the medicated plaster. 3\. Presence of skin diseases within the area of application. 4\. Patients with active peptic ulcer, patients with bronchial asthma, a history of gastrointestinal bleeding by nonsteroidal anti\-inflammatory drugs. 5\. History of alcohol or drug abuse. 6\. Known hypersensitivity to piroxicam, diclofenac or to any excipients or other nonsteroidal anti\-inflammatory drugs. 7\. Known hypersensitivity to paracetamol (rescue medication). 8\. Patients taking nonsteroidal anti\-inflammatory drugs until 48 hours before inclusion in the study or other drugs with high plasma protein binding. 9\. Patients on anticoagulant treatment. 10\. Patients who applied topical medication or steroids on the painful area within 48 hours before inclusion. 11\. Serious and unstable health conditions, including known and clinically relevant abnormalities in laboratory parameters. 12\. Concomitant medical condition that may affect the interpretation of the results of clinical trials. 13\. Fertile females. 14\. Participation in another clinical trial within 30 days prior to the selection for this protocol. 15\. Patients who are doing physical therapy. 16\. Patients already included in the present trial