Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT03936192
Status:
WITHDRAWN
Last Update Posted:
2022-04-18
First Post:
2019-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study
Sponsor:
Eurofarma Laboratorios S.A.
Organization:
Study Overview
Official Title:
Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
Brief 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.
Detailed Description:
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week treatment period, phase 3 comparative 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: