A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study
NCT03936192 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2022-04-18
Summary
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
Conditions
Interventions
- DRUG
-
glucosamine sulphate 1500mg and meloxicam 15mg
glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.
- DRUG
-
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)
- DRUG
-
Placebos
Placebo administered once daily for 12 weeks.
Sponsors & Collaborators
-
Eurofarma Laboratorios S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-31
- Primary Completion
- 2021-02-28
- Completion
- 2021-02-28
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