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

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862977
• Other study ID #: EMS1415
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 20, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Drug:
• ketoprofen and cyclobenzaprine association with caffeine
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
• Cyclobenzaprine with caffeine
The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo
Brazil	CECIP JAU - Centro De Estudos Clinicos do Interior Paulista	Jau	SP
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	Marcio Antonio Pereira Clinica de Endocrinologia	São José dos Campos	São Paulo
Brazil	AFIP -Associação Fundo de Incentivo a Pesquisa	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.		48 hours
Secondary	Safety will be evaluated by the adverse events occurrences		Maximal experiment duration: 9 days