Clinical Study of Non-inferiority With Participants Diagnosed With Primary Knee OA (GLACIAL)
Status:
Completed
Trial end date:
2019-05-10
Target enrollment:
Participant gender:
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.