Assessment of therapeutic equivalence, tolerability and patients satisfaction in subjects affected of neck pain treated with medicated plasters containing piroxicam or diclofenac.
- Conditions
- cervical pain of osteoarthritic originMedDRA version: 14.1Level: LLTClassification code 10008322Term: CervicalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-000023-33-IT
- Lead Sponsor
- S.P.A. ITALIANA LABORATORI BOUTY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method