Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

Phase 3

Completed

• Conditions: Musculoskeletal Pain
• Interventions: Drug: ketoprofen and cyclobenzaprine association with caffeine; Drug: Cyclobenzaprine with caffeine

• Registration Number: NCT02862977
• Lead Sponsor: EMS

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

Study Timeline

• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Study Start: 2017-11-10
• Primary Completion: 2019-06-05
• Study Completion: 2019-12-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMS association	ketoprofen and cyclobenzaprine association with caffeine	The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
Miosan Caf®	Cyclobenzaprine with caffeine	The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h.

Primary Outcome Measures

Name	Time	Method
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.	48 hours

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	Maximal experiment duration: 9 days

Trial Locations

Locations (6)

Marcio Antonio Pereira Clinica de Endocrinologia; 🇧🇷 São José dos Campos, São Paulo, Brazil

Associação dos funcionários públicos do estado do RGS; 🇧🇷 Porto Alegre, RS, Brazil

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho; 🇧🇷 Porto Alegre, RS, Brazil

CECIP JAU - Centro De Estudos Clinicos do Interior Paulista; 🇧🇷 Jau, SP, Brazil

AFIP -Associação Fundo de Incentivo a Pesquisa; 🇧🇷 São Paulo, SP, Brazil

Allegisa; 🇧🇷 Campinas, São Paulo, Brazil