None listed
Conditions
Interventions
ZALDIAR Type of group
The study medication is ZALDIAR (Association of Tramadol 37.5 mg and Paracetamol 325 mg) formulated in tablets for oral administration for 7 days.
Group name:PLACEBO Type of group
The placebo formulated in tablets of the same characteristics as the active product will be given for 7 days.
Sponsors
GRUNENTHAL PERUANA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory patients suffering from subacute Iumbalgia, without radiculalgia, • Patients over 18 years old. • Patients able to take medication orally.
Exclusion criteria
Exclusion criteria: • Patients in whom treatment with Tramadol hydrochloride has previously failed or those who have discontinued treatment with Tramadol hydrochloride due to adverse events. • Patients who have taken Tramadol Hydrochloride in the 30 days prior to inclusion in the study. • Patients who have taken antidepressants or anticonvulsants for pain in the three weeks prior to the study. • Patients who have received sedative hypnotics, muscle relaxants in the 3 weeks prior to the study. • Patients who have taken short-acting analgesics (including paracetamol), nonsteroidal anti-inflammatory drugs, antihistamines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of the global pain intensity by means of the 10 cm Visual Analogue Scale (VAS) score, ranging from the absence of pain to the maximum pain imaginable, between OD (before treatment) and D3. The patient will evaluate during the visit the intensity of pain he felt in the last 24 hours. Measure:Analgesic efficacy of ZALDIAR (association of Tramadol 37.5 mg and Paracetamol 325 mg) in the treatment of acute and sub-acute lumbalgia and comparison to that of placebo. Timepoints:Day 3 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Evaluation of the overall pain intensity by means of the daily score of the Visual Analogue Scale (VAS) of 10 cm, ranging from the absence of pain to the maximum pain imaginable, between day 0 (before treatment) and day 7. The patient will evaluate the pain he felt in the last 24 hours. • Evaluation of the profile of the global pain intensity by means of the evolution of the daily score of the Analog Visual Scale, between day 0 and day 7. • Percentage of responding patients on each day of treatment, defined as those who achieve a reduction of more than 25% of the initial value recorded on the EVA scale. • Time until the response (reduction of more than 25% in the EVA score) from day 0. • Maximum efficiency, defined as the maximum difference in the EVA score between Day 0 and day of minimum score. • Time until the appearance of maximum efficiency. • Percentage of patients that require rescue medication, as well as number of doses per day. • Score in the Quebec questionnaire. • Score of the overall assessment of the treatment by the researcher, using the Global Clinical Impression scale. Measure:Functional assessment, pain interference in daily activities, using the Quebec questionnaire. Timepoints:day 3 y 7 | — |
Countries
Argentina, Chile, Colombia, Ecuador, Mexico, Peru, Venezuela
Outcome results
None listed