cervical pain of osteoarthritic origin MedDRA version: 14.1 Level: LLT Classification code 10008322 Term: Cervicalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: LENOTAC
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: PIROXICAM
CAS Number: 36322-90-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Sponsors
S.P.A. ITALIANA LABORATORI BOUTY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of piroxicam (applied daily with medicated plaster containing 14 mg) with that of diclofenac (applied twice daily with medicated plaster containing 180 mg) in patients suffering neck pain. Patches will be applied for 8 consecutive days. The clinical efficacy in the two treatment groups (consisting of 120 subjects each) will be assessed by comparing the difference (delta) of pain intensity measured by VAS (Visual Analogue Scale 0-100) at baseline and after 8 days of treatment. The two treatments will be considered equivalent if the difference in the average decrease (baseline - final) of the VAS between the two treatment groups will be less than or equal to 10 mm.;Secondary Objective: - Patient satisfaction degree. - Patient compliance. - Assessment of ''responders'' percentage. - Assessment of reduction in average daily pain. - Response time to treatment. - Proportion of patients achieving recovery. - Assessment of skin tolerance in the area of application. - The use of rescue medication to treat pain. - The degree of disability expressed on a verbal scale of 4-point. - The number of episodes in which the patch is partially or completely detached from the evaluated compilation of the diary study. - The percentage of patients who discontinued the study early for dissatisfaction with their assigned treatment.;Primary end point(s): To evaluate the clinical efficacy in the two treatment groups (piroxicam medicated plaster vs. diclofenac medicated plaster) comparing the difference (delta) of pain intensity measured by VAS (Visual Analogue Scale 0-100) at baseline and after 8-day treatment. The two treatments will be considered equivalent if the difference in the average decrease (baseline - final) of the VAS between the two treatment groups will be less or equal to 10 mm.;Timepoint(s) of evaluation of this end point: neck pain measured by VAS on day 1 and day 9 (8 days of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The patient satisfaction degree, expressed by visual analogue scale (VAS) at the end of study visit (V3). - The patient compliance. - Assessment of the percentage of ''responders'', meaning patients showing a pain reduction determined by VAS, at least 30%. - Assessment of reduction in average daily pain measured by VAS scale compilation. - Response time to treatment, meaning ''answering'' a pain reduction of at least 30% on the VAS scale, compared to the level of pain measured at baseline. - Proportion of patients achieving recovery (absence of pain, VAS = 0). - Assessment of the skin tolerability in the application area at day 5 (before application of the fifth patch) and at the end of the study, based on a scale of 8 levels. - The use of rescue medication to treat pain (measured as the amount of patients using rescue medication at least once). - The degree of disability (expressed on a verbal 4-point scale) assessed daily. - The number of episodes in which the patch is partially or completely detached. Data obtained by the diary study. - The percentage of patients who discontinued the study early for dissatisfaction with their assigned treatment.;Timepoint(s) of evaluation of this end point: Satisfaction degree (day 9, V3), patient compliance (every day), assessment of the responders (every day), mean reduction in pain symptoms (every day), response time (every day), patients achieving recovery (every day), assessment of skin tolerance (day 5 and 9, V2 and V3), use of rescue medication (every day), degree of disability (every day), adhesion patch (every day), percentage of patients who discontinued the study for dissatisfaction (day 5 and 9, V2 and V3) | — |
Countries
Italy
Contacts
Public ContactRICERCA CLINICA
MEDI SERVICE
Outcome results
None listed