NCT02830919

Clinical Study of Non-inferiority With Participants Diagnosed With Primary Knee OA (GLACIAL)

Phase III Clinical Study, Multicenter, Randomized, Single-blind, Parallel Groups for Safety Evaluation and Non-inferiority of Efficacy of Glucosamine Sulfate Plus Chondroitin Sulfate From Bovine Origin (Eurofarma Laboratorios S.A.) Versus Condroflex ® in the Treatment of Symptomatic Knee Primary Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This phase III clinical study will be conducted in Brazilian research sites. It will be included in the study 314 participants diagnosed with primary knee OA according to the classification criteria of the ACR. After a washout period, the participants will be randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate + chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment period of the study will be of 24 weeks. Each participant will perform seven visits to the research site. The main evaluations will be the improve of pain in the target knee by questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life by SF-12 questionnaire.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	Glucosamine and chondroitin sulfate combination (Eurofarma)
DRUG	Glucosamine and chondroitin sulfate combination (Zodic)

Timeline

• Start date: 2016-12-05
• Primary completion: 2019-05-10
• Completion: 2019-05-10
• First posted: 2016-07-13
• Last updated: 2019-10-09

Locations

4 sites across 1 country: Brazil