Clinical trial NCT02862977: Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment
Official title: Phase III, National, Multicenter, Randomized, Double-blind, Double-masked, Compare the Efficacy of Ketoprofen, Cyclobenzaprine and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Musculoskeletal Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

Detailed description: * Double-blind,randomized, multicenter
* Maximal experiment duration: 9 days
* 02 or 03 visits and a phone contact
* Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults.
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis;
* Renal or hepatic impairment.

Primary outcomes:
measure: Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
timeFrame: 48 hours
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: Maximal experiment duration: 9 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Associação dos funcionários públicos do estado do RGS
state: RS
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
state: RS
city: Jau
country: Brazil
facility: CECIP JAU - Centro De Estudos Clinicos do Interior Paulista
state: SP
city: São Paulo
country: Brazil
facility: AFIP -Associação Fundo de Incentivo a Pesquisa
state: SP
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
city: São José dos Campos
country: Brazil
facility: Marcio Antonio Pereira Clinica de Endocrinologia
state: São Paulo
Study officials:
References: